Endoluminal sleeve gastroplasty

ABSTRACT

Devices and methods of endolumenal formation of gastric sleeves are described. Some embodiments allow templating of a gastric sleeve by a gastric bougie, exposing a selected amount of tissue for suturing access, while maintaining sufficient internal working space for suturing within the template lumen.

RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.16/594,105, filed on Oct. 7, 2019, which is a continuation of U.S. Pat.Application No. 15/028,428 filed on Apr. 10, 2016, now U.S. Pat. No.10,433,998, which is a National Phase of PCT Patent Application No.PCT/IL2014/050893 having International Filing Date of Oct. 8, 2014,which claims the benefit of priority under 35 USC §119(e) of U.S.Provisional Pat. Application No. 61/889,099 filed on Oct. 10, 2013. Thecontents of the above applications are all incorporated by reference asit fully set forth herein in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof bariatric surgery and more particularly, to the endoluminal formationof gastric sleeves.

Obesity and related pathologies such as type 2 diabetes are of growingconcern worldwide. Gastrointestinal weight-loss surgery (bariatricsurgery) has been shown to be effective in achieving sustained weightloss and amelioration of type 2 diabetes. Gastric volume reductions viaopen surgical- or laparoscopic sleeve-gastrectomy have proven to be oneof the most effective forms of treatment.

Any surgical approach, however, no matter how minimally invasive, willstill struggle to meet demand due to the magnitude of this pandemic.Moderately obese patients, as well as vulnerable patients (children, forinstance) are underserved patient populations. Procedural cost-which canreach tens of thousands of dollars in the US, for example-is alsoprohibitive in places worldwide.

Furthermore, surgical procedures themselves are not without risks.Complications such as procedure-related leak, severity ofco-morbidities, and surgeon learning curve are but a few of the factorsthat have been, and will be, limiting extensive adoption of thisapproach.

In addition to being a relatively non-invasive form of gastric volumereduction procedure, endoluminal gastric sleeve formation carries thepotential for reduced risk of leakage from the stomach. Because thestomach itself is optionally left intact, another potential advantage ofan endoluminal technique over sleeve formation by surgical resection isreversibility, for example, in case of complications. Devices andmethods for endoluminal gastric sleeve formation are described, forexample, in: U.S. Pat. Publication 2008/0249404 by Mikkaichi et al.filed Dec. 27, 2007; U.S. Pat. 6,558,400 to Deem et al. filed May 30,2001; U.S. Pat. 7,896,890 to Ortiz et al. filed Mar. 1, 2011; and U.S.Pat. 7,083,629 to Weller et al. filed Aug. 1, 2006.

SUMMARY OF THE INVENTION

There is provided in accordance with some embodiments of the invention abougie for shaping a stomach portion to receive sutures, comprising:

-   (a) a flexible wall sized and shaped to define a gastric passageway    for food;-   (b) a plurality of spaced wall fenestrations longitudinally    distributed along the flexible wall, wherein-   a geometry of at least some of said fenestrations is modifiable    while said bougie is in a stomach to receive a thickness of gastric    muscle for suturing.

In some exemplary embodiments of the invention, said fenestrations arearranged so that a first fenestration receives tissue from one side ofthe stomach and a second fenestration receives tissue from a facing sideof the stomach, when vacuum is applied to said first and secondfenestrations. Optionally or alternatively, said wall defines a lumen,is sized for transoral insertion to a stomach, and is stiff enough towithstanding a vacuum pressure sufficient to collapse tissue of thestomach onto the flexible wall.

In some exemplary embodiments of the invention, said plurality comprisesat least 8 fenestrations.

In some exemplary embodiments of the invention, said fenestrations arearranged in pairs at same axial locations.

In some exemplary embodiments of the invention, said fenestrations arearranged in alternating order on either side of a lien along saidbougie.

In some exemplary embodiments of the invention, said fenestrations aredefined as cutouts from said wall.

In some exemplary embodiments of the invention, said fenestrations eachdefine a collar for guiding tissue ingress. Optionally, said collarextends radially away from a surface of said wall.

In some exemplary embodiments of the invention, said fenestrations areconfigured to receive an amount of gastric tissue suitable fornon-penetrating suturing by maintaining at least an outside layer ofsaid gastric tissue outside of an axial lumen defined by said wall.

In some exemplary embodiments of the invention, the bougie comprises ablocker, wherein said blocker, extends along the flexible wall such thatit diminishes open area within at least one fenestration, and whereinsaid blocker is moveable to increase the open area of at least oneselected fenestration and wherein the fenestrations are being sized andshaped, when said open area is increased, to admit a predeterminedthickness of a gastric wall of said stomach for suturing. Optionally,said blocker bisects said open area into a plurality of open areas, eachacting as a fenestration. Optionally, a first open area of saidplurality of areas is positioned to receive a portion of said stomachtissue from a first portion of the gastric wall, and a second open areaof said plurality of areas is positioned to receive a portion of saidstomach tissue from a second portion of the gastric wall; the first andsecond portions of the gastric wall being connected through a band ofgastric wall wrapping around the bougie.

In some exemplary embodiments of the invention, the blocker is moveableto selectively open said selected fenestration in an order from a moredistal cutout region to a more proximal cutout region. Optionally, saidblocker is configured to be so movable after suturing so as to releaseitself from gastric tissue sutured around it. Optionally, said blockeris in the form of a strip or a cylinder.

In an exemplary embodiment of the invention, the bougie comprises atleast one fenestration having its entire area blocked by the blocker,the blocker being moveable to at least partially open the blocked area.Optionally, said blocker is moveable to increase the at least partiallyopen blocked area to admit a predetermined thickness of a gastric wallof said stomach for suturing.

In some exemplary embodiments of the invention, said predeterminedthickness allows insertion of a needle into said gastric wall to withina selected range of tissue depths.

In some exemplary embodiments of the invention, said fenestrations arearranged to guide uniform suturing along said stomach.

In some exemplary embodiments of the invention, said selected range oftissue depths is between 2 mm and 6 mm.

In some exemplary embodiments of the invention, said predeterminedthickness is predetermined by a geometry of said fenestration.

In some exemplary embodiments of the invention, said fenestrationscomprise periodic widenings of a cut away portion of the flexible wallalong a longitudinal axis of the bougie. Optionally, said periodicwidenings occur between every cm to 2.5 cm.

In some exemplary embodiments of the invention, said blocker occupies atleast 20% of the width of the fenestrations it crosses.

In some exemplary embodiments of the invention, different ones of saidfenestrations have different sizes when unblocked.

In some exemplary embodiments of the invention, an angular distancebetween a pair of fenestrations is between 20 and 50 degrees, a width ofeach of said pair is between 6 and 8 mm and said predetermined depth isbetween 1 and 2.2 mm, while leaving at least a serosa layer out of saidbougie and a distance between the centers of axially separatedfenestrations is between 0.7 and 1.2 mm.

In some exemplary embodiments of the invention, the bougie has a curvedlongitudinal axis in a resting state thereof.

In some exemplary embodiments of the invention, said fenestrations arearranged axially such that a longitudinally advancing needle can suturetissue in said fenestrations to each other and form a gastric sleevetherefrom.

In some exemplary embodiments of the invention, the bougie comprises atleast two inflatable elements, one on either end of said bougie andconfigured to expand an amount sufficient to seal a stomach enclosingsaid bougie.

In some exemplary embodiments of the invention, the bougie comprises atleast one shaping element radially extending away form said bougie andarranging a collapse of said stomach when vacuum is applied to saidbougie. Optionally, said shaping element extends to a portion of saidstomach opposite said bougie and applies a pushing force thereagainst.

In some exemplary embodiments of the invention, said bougie has aninterior lumen large enough to allow the insertion of a 7 mm diametervideoscope for imaging said predetermined thickness of tissue.

In some exemplary embodiments of the invention, said blocker istransparent for optical imaging therethrough.

In some exemplary embodiments of the invention, the bougie is providedas a system including a suturing needle. Optionally, said needle ishelical.

In some exemplary embodiments of the invention, the bougie is providedas a system including at least one non-thread suture.

In some exemplary embodiments of the invention, the bougie is providedas a system including at least axially retracting suture applicator.

In some exemplary embodiments of the invention, the bougie is providedas a system including a connection to a vacuum source and a leakindicator.

There is provided in accordance with some embodiments of the invention abougie for shaping a stomach portion to receive sutures, comprising:

-   (a) a flexible wall sized and shaped to define a gastric passageway    for food;-   (b) a plurality of at least four spaced wall fenestrations    longitudinally distributed along the flexible wall, wherein-   said plurality of fenestrations have a geometry adapted to guide a    predetermined thickness of gastric muscle for suturing to be sucked    into said fenestrations and held thereby.

There is provided in accordance with some embodiments of the invention asystem for gastric reshaping including:

-   a bougie for shaping a stomach portion to receive sutures,    comprising-   a flexible wall sized and shaped to define a gastric passageway for    food; and-   a proximal expandable element and a distal expandable element spaced    apart a distance suitable for sealing said stomach while vacuum is    applied to said stomach via a fenestration in said bougie to    collapse said stomach on said bougie. Optionally, the system    comprises at least one sensor and circuitry receiving a signal from    said sensor and configured to generate an alert when a leak in said    stomach is indicated by said sensor. Optionally, said sensor detects    a change in vacuum pressure in said bougie.

There is provided in accordance with some embodiments of the invention abougie for shaping a stomach portion to receive sutures, comprising:

-   (a) a flexible wall sized and shaped to define a gastric passageway    for food;-   (b) a plurality of spaced wall fenestrations longitudinally    distributed along the flexible wall and configured to receive a    thickness of gastric muscle, from opposing stomach walls, for    suturing; and-   (c) a tissue arranger positioned to control a collapse of said    stomach when vacuum is applied to said fenestrations. Optionally,    said arranger extends to a wall of said stomach opposite said    bougie. Optionally or alternatively, said arranger arranges tissue    near said fenestrations.

There is provided in accordance with some embodiments of the invention amethod of gastric sleeve creation, comprising:

-   inserting bougie into a stomach;-   applying a vacuum to collapse said stomach on said bougie; and-   detecting a penetration through said stomach wall, based on a change    in one or more property of said vacuum. Optionally, applying    comprises applying through a plurality of fenestrations in said    bougie and also comprising receiving gastric wall tissue in said    fenestrations and piecing said tissue n a non-penetrating manner    which does not exit said stomach. Optionally or alternatively, said    detecting comprises detecting change in said vacuum. Optionally or    alternatively, the method comprises sealing said stomach using at    least one sealing balloon.

There is provided in accordance with some embodiments of the invention amethod of intralumenally suturing a gastric sleeve, comprising:

-   inserting into a stomach a bougie having a wall comprising a    plurality of separated fenestrations;-   drawing vacuum through said bougie, such that stomach tissue from    opposing sides of the stomach is drawn to the bougie wall, wrapping    around it, and partially intruding into said fenestrations, one such    side in each portion of the bisected cutaway regions; and-   suturing the drawn tissue from two sides to each other,-   wherein a geometry of said fenestrations is modified before, during    or after said suturing. In some exemplary embodiments of the    invention, said fenestrations are separated by a strip and said    suturing is around said strip and comprising withdrawing the blocker    strip, freeing the sutured tissue. Optionally or alternatively, said    fenestrations are selected to have a circumferential width of    between about twice the combined thickness of a muscosa layer and a    muscular layer and about twice the combined thickness of a muscosa    layer, a muscular layer and serosa layer. Optionally or    alternatively, the method comprises sequentially:    -   removing the partial block on said partially blocked cutaway        regions such that the tissue from the two sides of the stomach        wall intrudes more deeply into the bougie lumen,    -   and suturing the more deeply intruding tissue from the two sides        of the stomach wall together. Optionally or alternatively, said        modifying comprises increasing a size of said fenestrations such        that the tissue from the two sides of the stomach wall intrudes        more deeply into the bougie lumen, prior to said suturing.

In some exemplary embodiments of the invention, the method comprisesviewing said tissue from within said bougie prior to said suturing.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

As will be appreciated by one skilled in the art, aspects of the presentinvention may be embodied as a system, method or computer programproduct. Accordingly, aspects of the present invention may take the formof an entirely hardware embodiment, an entirely software embodiment(including firmware, resident software, micro-code, etc.) or anembodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects of the present invention may take the form of acomputer program product embodied in one or more computer readablemedium(s) having computer readable program code embodied thereon.Implementation of the method and/or system of embodiments of theinvention can involve performing or completing selected tasks manually,automatically, or a combination thereof. Moreover, according to actualinstrumentation and equipment of embodiments of the method and/or systemof the invention, several selected tasks could be implemented byhardware, by software or by firmware or by a combination thereof usingan operating system.

For example, hardware for performing selected tasks according toembodiments of the invention could be implemented as a chip or acircuit. As software, selected tasks according to embodiments of theinvention could be implemented as a plurality of software instructionsbeing executed by a computer using any suitable operating system. In anexemplary embodiment of the invention, one or more tasks according toexemplary embodiments of method and/or system as described herein areperformed by a data processor, such as a computing platform forexecuting a plurality of instructions. Optionally, the data processorincludes a volatile memory for storing instructions and/or data and/or anon-volatile storage, for example, a magnetic hard-disk and/or removablemedia, for storing instructions and/or data. Optionally, a networkconnection is provided as well. A display and/or a user input devicesuch as a keyboard or mouse are optionally provided as well.

Any combination of one or more computer readable medium(s) may beutilized. The computer readable medium may be a computer readable signalmedium or a computer readable storage medium. A computer readablestorage medium may be, for example, but not limited to, an electronic,magnetic, optical, electromagnetic, infrared, or semiconductor system,apparatus, or device, or any suitable combination of the foregoing. Morespecific examples (a non-exhaustive list) of the computer readablestorage medium would include the following: an electrical connectionhaving one or more wires, a portable computer diskette, a hard disk, arandom access memory (RAM), a read-only memory (ROM), an erasableprogrammable read-only memory (EPROM or Flash memory), an optical fiber,a portable compact disc read-only memory (CD-ROM), an optical storagedevice, a magnetic storage device, or any suitable combination of theforegoing. In the context of this document, a computer readable storagemedium may be any tangible medium that can contain, or store a programfor use by or in connection with an instruction execution system,apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium may be transmittedusing any appropriate medium, including but not limited to wireless,wireline, optical fiber cable, RF, etc., or any suitable combination ofthe foregoing.

Computer program code for carrying out operations for aspects of thepresent invention may be written in any combination of one or moreprogramming languages, including an object oriented programming languagesuch as Java, Smalltalk, C++ or the like and conventional proceduralprogramming languages, such as the “C” programming language or similarprogramming languages. The program code may execute entirely on theuser’s computer, partly on the user’s computer, as a stand-alonesoftware package, partly on the user’s computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user’s computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider).

Aspects of the present invention may be described below with referenceto flowchart illustrations and/or block diagrams of methods, apparatus(systems) and computer program products according to embodiments of theinvention. It will be understood that each block of the flowchartillustrations and/or block diagrams, and combinations of blocks in theflowchart illustrations and/or block diagrams, can be implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable data processingapparatus, create means for implementing the functions/acts specified inthe flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example, and for purposes ofillustrative discussion of embodiments of the invention. In this regard,the description taken with the drawings makes apparent to those skilledin the art how embodiments of the invention may be practiced.

In the drawings:

FIGS. 1A-1B schematically illustrate bougie-templated surgical formationof a gastric sleeve with partially isolated gastric pocket, according tosome exemplary embodiments of the invention;

FIG. 1C schematically illustrates an exemplary bougie for use increating a gastric sleeve, according to some exemplary embodiments ofthe invention;

FIG. 1D is a schematic flowchart of a process of positioning a bougie inpreparation for suturing, according to some exemplary embodiments of theinvention;

FIG. 1E is a schematic flowchart of a process of suturing gastric wallstogether using a bougie, according to some exemplary embodiments of theinvention;

FIGS. 1F-1G schematically illustrate conversion of bougie gastriccompartment sealing balloons from a deflated to an inflated state,according to some exemplary embodiments of the invention;

FIGS. 1H-1I schematically illustrate bougie with blocker partiallywithdrawn to merge a portion of its paired fenestration rows, accordingto some exemplary embodiments of the invention;

FIGS. 2A-2C schematically illustrate the position of gastric wall tissuearound cross sections of a positioned bougie under vacuum, the walltissue being prevented from free entry to the lumen of the bougie by ablocker, according to some exemplary embodiments of the invention;

FIG. 3A schematically illustrates the invagination of gastric walltissue to a bougie upon application of vacuum, according to someexemplary embodiments of the invention;

FIG. 3B schematically illustrates the further invagination of gastricwall tissue into a bougie upon removal of strip while vacuum continuesto be applied, according to some exemplary embodiments of the invention;

FIGS. 4A-4B schematically illustrate alternative suturing situations,according to some exemplary embodiments of the invention;

FIG. 4C schematically illustrates penetration by a needle under thecontrol of a needle holder into superficial regions of gastric walltissue, according to some exemplary embodiments of the invention;

FIGS. 4D-4E schematically illustrate cutaway side-views of suturing fromwithin a bougie, according to some exemplary embodiments of theinvention;

FIGS. 4F-4G schematically illustrate the potential for interference ofproximal tissue intrusions on the suturing of more distal tissueintrusions within a bougie, according to some exemplary embodiments ofthe invention;

FIG. 4H schematically illustrates suturing at a level of the bougie witha blocker in place, according to some exemplary embodiments of theinvention;

FIG. 5 schematically illustrates the configuration of inflatable bougieanchoring balloons, according to some exemplary embodiments of theinvention;

FIGS. 6A-6C schematically illustrate conversion of balloons from adeflated to an inflated state while in position within a stomach,according to some exemplary embodiments of the invention;

FIGS. 7A-7D schematically illustrate a bougie configured with a blockerslider shaped to allow either full or partial blockage ofpositioning/suture windows, according to some exemplary embodiments ofthe invention;

FIGS. 7E-7F schematically illustrate perspective and perspective detailviews of a bougie, according to some exemplary embodiments of theinvention;

FIGS. 7G-7J schematically illustrate a bougie comprising a blocker forwhich the size and/or position of the blocking region is controlled byhelical motion, according to some exemplary embodiments of theinvention;

FIGS. 8A-8B schematically illustrate a bougie comprising fenestrationswherein depth of tissue penetration is adjusted by regions of variedwall thickness, according to some exemplary embodiments of theinvention;

FIGS. 9A-9B schematically illustrate a bougie comprising fenestrationswherein depth of tissue penetration is adjusted by regions of variedwall thickness, according to some exemplary embodiments of theinvention;

FIGS. 10A-10M schematically illustrate, different dimensions offenestrations, having different effects on function, according to someexemplary embodiments of the invention;

FIGS. 11A-11C schematically illustrate bougies having variable width,variable fenestration dimensions, and/or variable blocker dimensions,according to some exemplary embodiments of the invention;

FIGS. 11D-11G show alternative arrangements of bougie blockers, andtheir mounting regions, according to some exemplary embodiments of theinvention;

FIGS. 12A-12D schematically illustrate different shapes of bougiebodies, according to some exemplary embodiments of the invention;

FIG. 12E is a schematic perspective illustration of a fenestratedbougie, wherein suturing by a needle held by a holder is carried outunder observation by an endoscope, according to some exemplaryembodiments of the invention;

FIG. 12F is schematic cross section of a bougie body having a slotregion for assisting positioning of a needle, according to someexemplary embodiments of the invention;

FIGS. 13A-13C show bougies, comprising stomach positioning/sizingextensions, according to some exemplary embodiments of the invention;

FIGS. 13D-13E show bougies, comprising pylorus positioning/sizingextensions, according to some exemplary embodiments of the invention;

FIGS. 14A-14B show a multi-link gastric implant for forming anintra-gastric sleeve, according to some exemplary embodiments of theinvention;

FIG. 15 shows the multi-link gastric implant of FIGS. 14A-14B,straightened according to some exemplary embodiments of the invention;

FIG. 16 shows a cross-section of a multi-link gastric implant havinggastric wall tissue recruited to its hooks, according to some exemplaryembodiments of the invention;

FIGS. 17A-17B show a self-securing clip for securing two gastric wallparts to one another, according to some exemplary embodiments of theinvention;

FIGS. 18A-18B show a distal segment of a delivery system comprising arow of self-securing clips for securing two gastric wall parts to oneanother, according to some exemplary embodiments of the invention;

FIGS. 19A-19F show details of the construction of a shaft of a deliverysystem for self-securing clips, according to some exemplary embodimentsof the invention;

FIGS. 20A-20C demonstrate a sequence of approximating a segment of thestomach’s walls, according to some exemplary embodiments of theinvention;

FIGS. 21A-21C demonstrate a clipping device integrated with conventionalgastrointestinal means such as bougie and endoscope/gastroscope,according to some exemplary embodiments of the invention;

FIGS. 22A-22B illustrate a semi-automatic suturing device, according tosome exemplary embodiments of the invention; and

FIGS. 23A-23D demonstrate the driving mechanism of a suturing needle,according to some exemplary embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof bariatric surgery and more particularly, to the endoluminal formationof gastric sleeves.

Overview

A broad aspect of some embodiments of the current invention relates todevices and methods for the endoluminal formation of a gastric sleeve,for the control of patient weight and related health issues, optionallyin a fast and/or reliable manner.

In some cases, for a method of endoluminal formation of a gastric sleeveto reach wide availability, it should be both rapid and reliable. Someproposed automated and semi-automated solutions for rapid formationenvision “blind” formation of a gastric sleeve, where tissue is formedby vacuum to a putatively known location, so that a securing device canbe driven through it along a predetermined pathway. Potential drawbacksof such approaches arise in the context of variable anatomy, incorrectinitial positioning (in cases where this is difficult to verify), and/ormovement during the procedure, even if positioning is initially correct.Some or all of these drawbacks may be avoided or mitigated using someembodiments of the invention.

The fine manipulations often associated with (thread-type) suturingsuggest a potential for slowness and/or technical difficulty, given theconfined space in which an endoluminal gastric sleeve must be created. Atypical gastric sleeve diameter, for example, has a nominal diameter ofabout 12.5 mm, up to about 20 mm. In part to obviate the need for suchsuturing, attachment means alternative to surgical suture have beenproposed for formation of a gastric sleeve, including surgical staples,helical wires, clips, and attachment cups.

One alternative is barbed (“knotless”) sutures (whose resistance tobreakage becomes more dependable). Barbed sutures potentially are morerapidly placed than traditional sutures, since the need for knotting isremoved or reduced. Barbed sutures distribute stress more evenly alongtheir length, potentially reducing the occurrence of focal tearing oftissue. Barbed sutures are more easily placed in confined surgicalsituations. In some cases it may be desirable for a practitioner to beable to clearly visualize the work area, for example by the use of anendoscope (typically, a videoscope-type endoscope).

Another suturing solution exists in the form of endoscope-mountedsuturing machines. However, the endoscope itself can be more than 1 cmin diameter, for example, to allow repositioning thereof and a suturingmachine adds further bulk.

In an exemplary embodiment of the invention, there is provided methodsand/or apparatus for endoluminal sleeve gastroplasty, for creatingcontrollable, well-defined, and/or verifiable conditions for theguidance of sleeve formation that are also optionally consistent withproviding enough space for the use of sutures and suture-like attachmenttechnologies, though it is noted that some embodiments do not usesutures. It should be understood that one or more of the elements ofcontrol, definition and verification are optionally used with otherforms of attachment, such as staples, pins, clips, helical inserts,tissue adhesives, and/or other devices. Except where features relatingspecifically to suturing as such are described herein, it is to beunderstood that references to suturing are exemplary and not limiting,and include reference also other forms of tissue connection as well.

An aspect of some embodiments of the current invention relates to theprovision of adaptable fenestrations, and methods for the use thereof,which allow and/or support controlled, optionally variable, gastric wallintrusion into a bougie adapted to form a template for a gastric sleeve.

In some embodiments, a bougie (e.g., a form of medical device comprisinga hollow body which is generally cylindrical), with a size andflexibility appropriate for insertion transorally into the gastriccavity, is adapted for use as a template for the formation of a gastricsleeve, for example, based on its size, shape and/or other properties,including dynamic properties, as described herein. Bougie-templating isused in different forms of gastric reduction, including sleeve formationby gastrectomy. Some embodiments of the invention comprise bougiemodifications which add new functions to this common element of gastricreduction.

In some embodiments, the bougie is provided with one or more openings towhich vacuum is applied (for example from outside the stomach), causingthe stomach walls to collapse around it. Optionally, if the Bougie iscylindrical, the collapse is generally cylindrical, at least over mostof a circumference of the bougie. Optionally, the bougie includes one ormore elements to seal some or all of the stomach so the vacuum does not“escape” via other parts of the GI system and/or other openings in thestomach.

In some embodiments, endoluminal access to the walls is provided throughspecialized apertures, related to herein as fenestrations.

In some embodiments, fenestrations are configurable in geometry (e.g.,cross-sectional shape, connectivity and/or size and/or geometricalrelation between two or more fenestrations) during formation of agastric sleeve to select among at least two states. In some embodiments,a wall positioning state of a fenestration holds gastric wall tissue ina position consistent with “gastric sleeve templating”, but prevents itfrom materially interfering with manipulation and/or visualization oftissue distal to it. A suture presentation state, in some embodiments,allows tissue to intrude into the bougie to a distance which presents aprofile for suturing. In some embodiments, suturing or other attachmentties the bougie together with the tissue of the stomach in a suturepresentation state, while entry into a third and/or alternative state, asuture-freeing state, breaks this connection, freeing the bougie fromconnection with the stomach. In some embodiments, the position of theblocker is the same for two or more states (for example, the positioningstate and the suture presentation state are the same). In someembodiments, the transition among states, and/or configuration of thestate itself is gradually selectable; for example, a fenestration sizeis gradually adjustable from a fixation/positioning state to select adesired tissue penetration depth for presentation of tissue for suturingin a suture presentation state. In some embodiments, a tissue exclusionstate entirely prevents the intrusion of gastric wall tissue to thebougie at the level of a fenestration, until a selected stage of thesleeve formation procedure. In an exemplary embodiment of the invention,fenestration geometry (e.g., in a circumferential direction and/or axialdirection) for presentation for suturing is between 2*(ML+GM) and2*(ML+GM+SL), where ML is a thickness of the muscosa layer, GM is athickness of the gastric muscle layer and SL is a thickness of theserosa layer. The geometry may be different, for example, be up to 20%greater or smaller (or more), for example, if a collar surrounds thefenestration.

In some embodiments, the transition between states is accomplished bythe movement of a blocker device, which selectively blocks and unblocksportions of the fenestrations. In some embodiments, the blockerdevice-alternatively or additionally-divides fenestrations into two ormore parts, creating an effective reduction of size which also serves asa form of blocking. In some embodiments, there are two modes of statetransition - transition of size, in which fenestrations are made largeror smaller, and “topological” transition, wherein two or more separatedfenestrations merge, or a single fenestration aperture is divided. Insome embodiments, only one of these modes is used. In some embodiments,transition involves compound movements and transitions-for example,merging two windows across a short slit opening to free a suture bypassing it through the slit, then re-dividing the windows for exclusionof tissue from the bougie lumen.

A blocker device, in some embodiments, comprises, for example, a strip,tube, helix, and/or other part, attachedly insertable with, and alsosuitable for movement relative to the body of the bougie. The blockeroptionally comprises a single piece, or two, three, or more piecescapable of such relative motion. A blocker is moved, for example, byaxial translation along the bougie, and/or a form of lateral movement,such as rotational movement within or around the bougie.

In some embodiments, a blocker device is initially positioned to convertan array (for example an axially distributed row) of fenestrations tovacuum ports, suitable for grabbing and positioning portions of thegastric wall near to one another in preparation for suturing. In someembodiments, the ports in vacuum-port mode prevent intrusion of tissueinto the bougie lumen, the prevention being to the extent necessary toallow visualization of portions more distal, while still forming avacuum connection.

In some embodiments, a blocker device is re-positionable to convertfenestrations (for example, a pair of divided fenestrations at a time)into a suture-presenting mode. In a suture-presenting mode, afenestration allows entry of tissue, for example under vacuum pressure,such that a depth of tissue is presented into which a suture needle orother attachment device can be reliably inserted to within a selectedrange of tissue depths.

In some embodiments, suture-presenting mode and vacuum-port mode are thesame for a fenestration pair, the blocked fenestration dimensions beingsized and shaped for correctly measured intake of tissue for suturingwhile the blocker is in place (rather than afterward). This can be forall fenestrations of the bougie, or with some fenestrations beingdifferently seized, e.g., being properly sized for presentation oftissue for suturing upon blocker removal. Additionally or alternatively,the suture-presenting and vacuum-port modes can be the same for somefenestrations/usage scenarios (for example, in patients and/or locationswhere gastric wall tissue is relatively thin), and separately selectablefor others (for example, in patients/locations where gastric wall tissueis relatively thick).

In some embodiments of the invention, removal of a blocker comprisesentry into a suture-freeing mode. Optionally, a blocker is left in placeduring suturing, such that a suture joins two parts of stomach wallaround the blocker itself. For example, that the suture is placedbetween the blocker and another portion of the bougie to which it joins,temporarily locking stomach and bougie together. In some embodiments,removal of the blocker by sliding through the sutured region frees thebougie from the sutured stomach.

It is noted that in some embodiments, at a single time, differentfenestrations can be in different states, for example, due to partialretraction of the blocker.

In some embodiments, the fenestrations are not in parallel pairs. Forexample, here may be alternating pairs and/or pairs with only partial,or no axial overlap. In some embodiments, the fenestrations are arrangedalong a line, but the line is curved and/or is not in a single plane.This may allow not cylindrical sleeves to be created. Optionally oralternatively, the bougie itself is curved, optionally in more than onedirection and/or its axis does not lie in a single plane.

An aspect of some embodiments of the invention relates to fenestrationgeometry which encourages a correct penetration depth. In someembodiments, the selected presentation depth is configured (e.g., bydesign and/or manipulation during use and/or selection from a range ofbougies and/or bougie inserts such as in the shape of a thin slottedcylinder) to be dependably within a range which both assures access tothe relatively tough muscular layers of the gastric wall (normallyburied under 1-3 mm or more of mucosa and submucosa), and helps avoidpenetration of a needle (or other suturing tool) past the muscular layerand/or serosa to perforate the gastric wall. It should be understoodthat the muscular layers themselves are typically only 1-3 mm thickthemselves, so the degree of tissue intrusion allowed is potentially acritical parameter for reliable success.

In some embodiments, proper positioning comprises selection of one ormore of fenestration size, bougie wall diameter, bougie wall thickness,and/or blocker size, according to a working level along the bougie axis.Typically, the anatomy of the stomach wall is variable along thisdimension, being often thickest near the cardia, and growing thinnernear the pylorus. In some embodiments of the invention templatedimensions which vary as a function of this anatomy, such that reliablesuturing can be performed to reduce risk of tearing (too shallow asuture) and/or perforation (too deep a suture). In some embodiments,presentation is controlled by not allowing penetration to be too deep,due to tissue exclusion from the bougie. In some embodiments,presentation is controlled by allowing tissue depths to be judged, forexample, according to landmarks and/or scaling indications visible onthe bougie in the working region of the tissue. In some embodiments,presentation is controlled by adding channels and/or restrictions to thepositioning of a needle or other attachment device. For example, achannel is cut into a portion of the fenestration wall into which aneedle or other fastening device is slotted so that it passes across thefenestration at a defined position, angle, and/or depth. Additionally oralternatively, an eye or lumen (optionally having a broken circumferenceto allow thread release) is provided for passage of needle therethrough.In some embodiments, a guide channel is continuous along the bougieand/or continuous between fenestration levels; for example, a spiraltrack passing from level to level along a portion of the length of thebougie. Such a track optionally is broken across a fenestration, butself-aligned so that it is easily found again upon crossing from oneside to the other. In some embodiments, provision is made so that aneedle or other leading edge of a fastening member can be drivencontinuously along such a track. Optionally, driving along the track isperformed under endoscopic visualization, such that positioning oftissue at each fenestration is potentially verifiable before suturingoccurs.

In some embodiments, an overall fenestration width is, for example, 6-8,8-10 mm, 9-13 mm, 11-15 mm, 14-17 mm, or another greater, larger, orintermediate width. In some embodiments, fenestrations are axiallyjoined to one another through a joining aperture, having a width of, forexample, 1-2 mm, 2-4 mm, 3-5 mm, or another greater, larger, orintermediate width. Optionally, the fenestrations are defined bywidenings occurring between such joining apertures. In some embodiments,fenestrations are separated axially. In some embodiments, fenestrationsare separated axially by, for example, 4-10 mm, 9-13 mm, 11-15 mm, 14-17mm, or another greater, larger, or intermediate length. In someembodiments, the axial length of fenestrations is, for example, about4-9 mm, 8-10 mm, 9-13 mm, 11-15 mm, 14-17 mm, or another greater,larger, or intermediate axial length. In some embodiments, the lateral(most separated) fenestration boundaries are separated, for example, byat an angle of about 20°-30°, 25°-40°, 30°-45°, 40°-60°, 50°-80°,75°-90°, or another greater, smaller and/or intermediate angle.

A consideration which potentially constrains, in some embodiments of theinvention, the period between fenestrations is the interval forsuturing. In a gastric sleeve where a non-food filling pocket is to beretained afterward, the sutures need be close enough together to preventthe passage of stomach contents, such that the sleeve forms a distinctcompartment. A spacing of about 2 cm is generally sufficient to ensurethis, though a different spacing is also used in some embodiments: forexample, 1-1.3 cm, 1.3-1.5 cm, 1.5-2.5 cm, 2.3-3.0 cm, 1.0-2.5 cm, oranother larger, smaller, or intermediate suture spacing. In someembodiments, an upper or lower region of the stomach is left unsutured,which, for example, allows secretions of the isolated stomach pocket tocontinue to enter the lower digestive tract and/or otherwise leave thestomach, even though the isolated region is kept substantially empty offood contents. A potential benefit of a lower opening is that it mayprevent undesired food ingress into the pocket and/or may supportstomach peristalsis. Optionally or alternatively, it may allow food toexit such a pocket by gravity and/or peristalsis. The provision of anopening may allow reversing of the operation, if desired.

In some embodiments, notionally single-aperture fenestrations havingdimensions, for example, as just listed, are divided into two aperturesduring some portion of gastric sleeve formation by a blocker device, forexample a blocker comprising a strip running through the center of thefenestration. In some embodiments, the blocker is just wide enough tocomprise a stable divider, for example, 1 mm wide, or potentially less.Potentially, such a fine divider serves primarily to resist filling of asingle fenestration by only one of the two gastric walls which are to beapproximated. In some embodiments, the blocker is wider: for example, 2mm, 3 mm, 4 mm, 5 mm, or another greater, smaller, or intermediatewidth. Wider blockers serve, for example, to prevent deep intrusion oftissue into the bougie during a portion of the gastric sleeve formationprocedure. In some embodiments, a blocker width varies along the axis ofthe bougie, for example through a width difference of up to 2 mm, 3 mm,4 mm, or another greater, smaller, or intermediate range of variability.A potential advantage of variable width is to allow adjustment todifferent thickness and/or convolution of the gastric wall along theaxial extent of the bougie. In some embodiments, the blocker extendsacross at least 20% of the total width of a fenestration that itobstructs. In some embodiments, it extends across, for example, at least30%, 40%, 50%, 75%, 90%, or another greater, smaller, or intermediatefraction of the width of a fenestration it crosses. In some embodiments,a blocker entirely blocks a fenestration it crosses. In someembodiments, a blocker defines the angle of arc separating twofenestrations. For example, fenestration medial sides (on either side ofa blocker) are separated by an angle (measured from the center of thebougie lumen, for example) of from about 0°-10°, 5°-20°, 10°-25°,20°-30°, or another greater, smaller and/or intermediate angle.

A potential problem for suturing through fenestrations of a bougie ismanagement of the topological issue of “sewing in” the bougie to thesuture line or locking by another connection means. In some embodiments,a blocker device is removable from a fenestration, either beforesuturing (which prevents the problem in the first instance), or aftersuturing (for example, by sliding the blocker device axially out of asuture in which it was originally involved). A potential advantage ofthe suture-then-remove approach is that the blocker device, while itremains in place, assists in stabilization of the suture line, even ifthe vacuum pressure should be deliberately or accidentally released.Potentially, it allows positioning and/or presentation for suture to bedetermined and set simultaneously, before suturing begins.

In some embodiments, for example as mentioned herein, a fenestrationmode is provided, wherein a fenestration is entirely blocked by ablocker during a portion of the procedure. This is a potentialadvantage, for example, to reduce the period of time spent under highvacuum by portions of tissue which are to be sutured. Another potentialadvantage is to allow positioning to be adapted over the course of theprocedure, by gradually “zipping up” the stomach wall from an initialstart point. In some instances, this is potentially an easier way ofcapturing the stomach wall than following an initial requirement tocapture the whole extent of the two opposing walls at once beforesuturing begins. Potentially, the choice between the two types ofprocedure is made at the onset of the surgery, and/or the choice can beto compromise between them-for example, to capture first a portion ofeach wall, then “zip up” the rest of the way once a stable base isestablished.

A potential advantage of some embodiments of the invention is when thedevice and/or method to be adaptable to variable conditions of thestomach of different patients, and/or the preferences and/or experiencelevel of different practitioners. It is also envisioned that thetechniques of endoluminal sleeve gastroplasty will continue to evolveover time, and it is a potential advantage for use of a device to beadaptable according to the specific requirements of a sleeve formationmethod.

In some embodiments, positioning of the stomach and/or the bougie isaided by the use of one or more positioning braces, configured to beinserted through and extendable from the bougie body. In someembodiments, the positioning brace comprises a preformed nitinol (orother super elastic or shape memory material) strip, inserted through achannel in the bougie, which returns to its preformed shape once insidethe stomach, to push on it so that the gastric sleeve channel isproperly formed upon application of vacuum, and/or so that the bougieends are properly positioned laterally within the stomach.

In some embodiments, a bougie is provided with inflatable balloons onone or both ends, which convert the gastric lumen into a vacuum-sealedcompartment when inflated. In some embodiments, one balloon inserts intothe pylorus, or an adjacent region, such that suction does not bring anygas or fluid back from the intestines. In some embodiments, a ballooninserts into the region of the esophagus, and/or the cardia, such thatsuction does not bring any gas down through the esophagus. In someembodiments, the amount of (gauge pressure) vacuum applied to secure thegastric wall tissue, and/or to pull an appropriate measured amount ofgastric wall tissue into the fenestrations of the bougie is about0.1-0.2 bar, about 0.2-0.4 bar, about 0.3-0.5 bar, about 0.4-0.6 bar, oranother range of pressures having the same, larger, smaller, and/orintermediate bounds. In some embodiments, pressure is stabilized towithin a range of about ±0.05 bar once sealing is applied. In someembodiments, pressure is stabilized to within a range of about ±0.01bar, ±0.03 bar, ±0.08 bar, ±0.1 bar, or another range of larger,greater, or intermediate pressures.

An aspect of some embodiments of the invention relates to a method ofdetecting inadvertent tissue penetration during an endoluminalgastroplasty procedure.

In some embodiments, a bougie provided with both pyloric region andesophageal/cardia region sealing stabilizes the vacuum pressure within abougie to such a degree that even a small leak (and/or a sudden changein pressure/flow) is detectable (e.g., using a pressure sensor coupledto the vacuum source and/or line to bougie and a controller and/or usingan alert system, for example an audio or visual alarm to alert apractitioner. Optionally, vacuum pressure is monitored during aprocedure, and a change in pressure alerted to a practitioner as apotential leak. In some embodiments, pressure is maintained by feedback,and a change in flow through a vacuum-maintaining apparatus detected,triggering an alert.

A potential advantage of the method is to allow immediate and/or at-willdetection of leakage conditions during a gastroplasty procedure, suchthat corrective measures can be undertaken. In particular, it is apotential advantage to have such information available as each suturingmovement occurs, as this may be more likely to allow rapid localizationof the problem for corrective action. In some embodiments, detection ofpressure change is sensitive to leakage to within a range of about±0.001 bar, ±0.005 bar, ±0.01 bar, ±0.05 bar, or another range oflarger, greater, or intermediate pressures.

An aspect of some embodiments of the invention relates to the provisionof a linear array of attachment points for defining the attachment lineof a gastric sleeve.

In some embodiments, a flexible chain of links is provided, withattachment means (for example hooks) provided along the chain of links.In some embodiments, the chain (in one or two parts) is attached alongeither side of the prospective attachment line between the two walls ofthe planned gastric sleeve. In some embodiments, the two gastric wallsides are attached by impaling a portion of the gastric wall on hooks orbarbs presented by the linear array device. In some embodiments, thelinear array of attachment points presented comprises defined suturingholes, or another surface for receiving an attachment device such as ahook, helix, clip and/or staple.

In some embodiments, the two parts of the linear array are configured toself-attach along the attachment line that closes the gastric sleeve.For example, the device comprises complementary attachment mechanismsalong the sleeve, wherein each link is attachable to a correspondinglink on the opposite wall of the sleeve. In some embodiments, attachmentis formed by pulling two ends of the attached device together, with theattachment forming automatically by interlocking. It is a potentialadvantage for the device to be self-locking, since this allows thedevice to be positioned so that it ends up on the outside of the gastricsleeve, away from the process of food digestion.

An aspect of some embodiments of the invention relates to the provisionof a self-attaching clip or staple, which is naturally “closed”, butwhich is held open until both walls of the stomach are put intoposition. Optionally, the clip is formed of nitinol, or another shapememory material. In some embodiments, a row of clips is provided, heldin an open position by a clip holder device. Optionally, vacuum isapplied to apertures of the clip holder, which tends to draw tissueclose to the clip ends. Optionally, the clip ends are sharpened and/orbarbed, to promote attachment to tissue which is drawn over them. Insome embodiments, the clips, once attached to each gastric wall, areallowed to bend to their natural position, securing the wall. Apotential advantage of self-securing clips is that the force of finalclosure need not be brought to bear externally, which is appropriate tothe cramped conditions of gastric sleeve formation.

An aspect of some embodiments of the invention relates to the provisionof a suturing device configured to drive a needle in a predefined patharound a helical pathway, the pathway being partially interrupted atintervals for the infilling of gastric wall tissue. In some embodiments,infilling of gastric wall tissue is promoted by the application ofvacuum, for example, via apertures of the helical pathway.

In some embodiments, the needle is driven by interacting along itslength with a ratchet mechanism, which presses on one or moreprotrusions from the needle to drive it around the helical pathway. Insome embodiments, the needle comprises a length which is relativelyshort compared to the length of the helical pathway it traverses. Forexample, the length of the needle is sized to follow two circuits of thehelical pathway, one circuit, half a circuit, a third of a circuit, aquarter of a circuit, or another greater, lesser, or intermediatelength. In some embodiments, the needle is driven by interactions at aplurality of regions along its length, such that it can continue to bedriven from behind the entrance side of tissue it enters until a portionof the needle exits the tissue. At the exit side, the needle is pickedup for advancement by interaction of the drive mechanism with theexiting portion of the needle, so that needle is advanced from in frontof the tissue, while the back portion of the needle continues thepassage through the tissue. In some embodiments, the needle is attachedto a suture line, which is drawn by the needle along the course of itshelical path. In some embodiments, parts of the suturing device arewithdrawn from within the suture line, and the suture line tightened inorder to form the final suture line of the gastric sleeve.

An aspect of some embodiments of the invention relates to a bougiehaving an array of fenestrations on each side of a line therealong andalso including a removable element which extends away from the bougie tohelp manage the stomach collapse towards the fenestrations. In someembodiments, the removable element comprises one or more baffles,optionally mounted on a movable blocker such as described herein andoptionally arranged to guide stomach tissue that is near thefenestrations to be on one side of the line or another. Optionally oralternatively, the movable element comprises an elongate element whichextends away from the bougie in a curved manner to engage a distant partof the stomach and push it away from the bougie.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings. The invention is capable of otherembodiments or of being practiced or carried out in various ways.

Bougie with Mutable Fenestrations

Reference is now made to FIGS. 1A-1B, which schematically illustratebougie-templated surgical formation of a gastric sleeve 16 withpartially isolated gastric pocket 18, according to some exemplaryembodiments of the invention. Reference is also made to FIG. 1C, whichschematically illustrates an exemplary bougie 100 comprising mutablefenestrations 108A, 108B, according to some exemplary embodiments of theinvention.

In some embodiments, fenestrations 108A, 108B are selectably mutable toperform various functions during the creation of a gastric sleeve 16.The functions include, for example, securing and/or releasing gastricwall tissue 20; and/or controlling gastric wall tissue exposure tosuturing tools within the bougie, for creation of a gastric sleeve. Insome embodiments, fenestrations 108A, 108B comprise fenestrations havingwidth, height, thickness, and/or spacing selected and/or selectable toexpose a chosen thickness of gastric wall tissue within the bougie (inparticular, under application of vacuum to the bougie), according to therequirements of a particular stage and/or position of gastric sleeveformation. In some embodiments, fenestration dimensions are changeable,for example by the movement of a blocker 102 or other spacing structure.In some embodiments, fenestration topology/connectedness is changeableby the movement of a blocker 102 or other framing structure. In someembodiments, different fenestrations are sized, spaced, and/oradjustable differently. This provides a potential advantage to adapt,for example, to variations in thickness and other anatomical features ofthe gastric wall along the length (the longitudinal axis) of the bougie100.

In some embodiments of the invention, a bougie 100, sized for esophagealinsertion (for example, 11-20 mm in diameter), is inserted into astomach 10. In some embodiments, the bougie assumes a curve through itsbody 120 which follows the curving anatomy of stomach 10 extending fromthe cardia at the base of the esophagus 14 to the region of the pylorus12. Vacuum is applied to wrap bougie 100 within the portion of stomachwall which is to form a gastric sleeve 16. Optionally, wrapping bringsthe walls together at approximation line 11. In some embodiments,attachment along approximation line 11 is performed to make a gastricsleeve; for example, by suturing. In some embodiments, bougie 100 iscomprised of a polymer allowing sufficient flexibility for insertion. Insome embodiments, the polymer is transparent, providing a potentialadvantage for visualization during positioning and/or suturing.Exemplary materials for construction include, for example, polyethylene,cyclic olefin copolymer, polycarbonate, polyolefin, polyurethane,fluorinated ethylene propylene, polyethylene and/or terephthalate. Insome embodiments, the flexibility of the bougie body is about 50-60Shore A, about 55-65 Shore A, about 50-80 Shore A or another range offlexibilities having the same, larger, smaller, and/or intermediatebounds. In some embodiments, different sections of the body havedifferent flexibilities; for example, short regions can be stiffer ifseparated by more flexible regions allowing transoral passage of thebougie. In some embodiments, the bougie comprises links of two or morematerials, for example, metal regions (which offer the potentialadvantage of added resistance to collapse under vacuum pressure), andplastic and/or rubber regions (providing flexibility). In someembodiments of the invention, the bougie comprises extruded polymermaterial.

In some embodiments, bougie 100 comprises fenestrations 108A, 108Bdistributed along a side of bougie body 120 away from the inner curve ofthe stomach 10. Fenestrations 108A, 108B comprise, when inserted to thestomach, avenues of communication between the walls of the stomach and aworking lumen of the bougie. In particular: fenestrations 108A, 108Bprovide one or more functions simultaneously and/or at different timesduring formation of a gastric sleeve. These functions are firstdescribed in general outline; other specifics are described in relationto the particular embodiments presented herein.

1. Fenestrations, in some embodiments, optionally function as portsthrough which suction, exerted upon the lumen of the bougie, can beapplied for positioning and/or fixation of portions of the gastric wall.In particular, in some embodiments, there are two rows of fenestrations108A, 108B located alongside each other on the outer curve of the bougiebody 120. Optionally, the fenestrations define an approximation line 11to which a portion of each of the two opposite walls of the stomach 10is brought in preparation for more permanent attachment, for example bysuturing. In some embodiments, other fenestrations (located, forexample, around the body of the bougie 100) also serve as vacuum ports.In some embodiments, balloons 106, 104 are located along the body of thebougie 100 at places such that can be inflated to seal against the entryof gasses from the pylorus 12 (balloon 106) and/or the esophagus 14(balloon 104) when vacuum is pulled. Potentially, this prevents leakage,stabilizing the vacuum. Potentially, this in turn helps stabilize thepositioning of tissue pulled against the fenestrations 108A, 108B of thebougie 100 by vacuum.

2. Fenestrations optionally function as view ports, allowing theobservation and/or alignment of the arrangement of stomach walls againstthe bougie. For example, a crease line formed where two gastric wallsapproximate to each other is observed through the fenestrations. In someembodiments, at least a portion of the bougie wall is transparent, sothat visualization is not limited to through the fenestrations.Nevertheless, the fenestrations optionally serve as alignment guides,particularly insofar as a usual goal during positioning is to moveand/or verify the crease defining the line of approximation to laybetween the two rows of fenestrations 108A, 108B, such that one wall isdrawn to the fenestrations of the left row, and the other to the right.

3. Fenestrations, in some embodiments, optionally function (for example,according to their size and/or shape) to limit the lumenal intrusion oftissue sucked to the bougie upon application of vacuum, for as long asthis limitation is needed. In some conditions, gastric wall pulled intoapposition with a fenestration by suction is prevented from intruding(or from intruding deeply) to the lumen of the bougie by the small size(in at least one dimension) of the fenestration. This is a potentialadvantage for preserving clear endoscopic access through the bougie, forexample, to sites at the distal end of the bougie for inspection,manipulation, and/or suturing. In some embodiments, the restriction ofintrusion is reversible during surgery, for example, upon withdrawal ofa blocker device 102.

4. Fenestrations, in some embodiments, optionally function to admittissue (for example, under suction) to a depth which is appropriate forthe application of a permanent attachment means. In some embodiments,fenestrations are sized to admit enough tissue that a muscular layer 22(FIG. 3B) of the stomach is accessible to penetration-for example by anendoscopically guided suture needle-but not so much tissue thatpenetration is likely to pass through the gastric wall entirely. Itshould be noted that a (healthy and normally distended) gastric walltypically comprises about 1.5-3 mm of mucosal and submucosal layers 24overlying another 1-3 mm of the muscular layers 22 (or, for example 2-4mm, or another thickness, depending on patient, stomach location, and/ordegree of distension). Permanent suturing which passes into musclespecifically is preferable, to provide sufficient strength anddurability of long-term attachment. Actually penetrating the gastricwall is preferably avoided, however, due, for example, to adverseeffects caused by leaking stomach secretions.

5. Fenestrations, in some embodiments, optionally function as ports forthe passage of needle and/or suture thread (and/or other attachmentmeans and/or equipment involved in forming attachment) from the lumen ofthe bougie into the gastric wall. In some embodiments, suturing takesplace entirely within the bougie lumen. However, in other embodiments,suturing involves passing a needle or other penetrating member and/orsuturing equipment at least partially, or even entirely, outside thebougie, and/or within the thickness defined by its walls.

6. Fenestrations, in some embodiments, optionally function totemporarily stabilize gastric wall tissue by involvement in the sutureitself. For example, in some embodiments, a suture thread is passed outof one fenestration, then back into another (optionally a plurality oftimes). This optionally temporarily ties the frame defining thefenestrations (the bougie) up with the gastric wall itself. In someembodiments, the bougie is configured so that the topology of thefenestrations can be changed to release them from this involvement,without cutting the suture thread. For example, a strip, guide, orinsert is configured to be removable from the bougie. Additionally oralternatively, framework separating fenestrations comprises gaps(permanent and/or openable) through which suturing work can be passed bysuitable manipulation. In some embodiments, temporary suturing to thebougie is used, optionally with penetration only to the mucosa, tostabilize and/or position the gastric wall to receive more stableprimary suturing. Optionally, stabilization by bougie-sewn sutures isleft in place to the end of a procedure. Optionally, stabilization isfocused around a working region of the growing suture line, with suturedregions being allowed to come free from fixation as the working regionmoves away from them.

7. Fenestrations optionally function to temporarily stabilize gastricwall tissue by another means. In some embodiments, for example,fenestrations can change shape to help grip and/or clamp gastric walltissue, potentially even in the absence and/or reduction of vacuumpressure. In some embodiments, a temporary securing device is applied totissue intruding into the bougie through a fenestration, for example apin and/or clamp. Optionally, the temporary securing device is itselfsized and/or shaped so that it cannot pass the frame of thefenestration, thus securing the tissue in place. Optionally, fixation isapplied either distal or proximal to a working region of the suture line(or both). Optionally, stabilization is iteratively added near themoving working region (region currently receiving suturing). Optionally,stabilization away from the working region is removed and/or relaxedbefore the end of the procedure.

Herein, bougie 100 is referred to in descriptions relating generally toa bougie comprising fenestrations according to some embodiments of thepresent invention. It should be understood that, insofar as particularsare applicable, such references also include other bougie embodimentscomprising fenestrations for gastric wall suturing (including but notlimited to bougies 300, 400, 500, and/or bougie embodiments includingone or more of the detail variants also described herein).

Defining the Gastric Sleeve

Reference is now made to FIG. 1D, which is a schematic flowchart of aprocess of positioning a bougie in preparation for suturing, accordingto some exemplary embodiments of the invention.

At block 160, in some embodiments, a bougie, such as bougie 100 oranother bougie, for example as described in relation to one or morefigures herein, is inserted to the stomach 10 through the esophagus 14.In some embodiments, the bougie diameter is between 32-60 Fr (about11-20 mm), or another diameter appropriate to esophageal insertion tothe stomach.

At block 162, in some embodiments, the bougie 100 is brought into itsinitial position. For example, in some embodiments, balloon sections104, 106 are placed where appropriate for balloon inflation, and/or thecurve of bougie 100 is made and/or brought into alignment with the innercurve of the stomach 10, for example as shown in FIG. 1A.

Reference is now made to FIGS. 1F-1G, which schematically illustrateconversion of balloons 104, 106 from a deflated to an inflated state,according to some exemplary embodiments of the invention. Reference isalso made to FIGS. 6A-6C, which schematically illustrate conversion ofballoons 104, 106 from a deflated to an inflated state, in positionwithin a stomach, according to some exemplary embodiments of theinvention.

In some embodiments of the invention, the distal end 121 of the bougie100 is inserted into the stomach so that it reaches to the region of thepylorus 12. Optionally the bougie is anchored by inflation of a balloon106. Optionally, the balloon 106 is situated in the pylorus 12,duodenum, and/or lower portion of the stomach 10 such that a sealresistant to vacuum is created when the balloon is inflated. Optionally,the bougie is anchored proximally by inflation of balloon 104.Optionally, the balloon 104 is situated in the esophagus 14, cardia,and/or upper portion of the stomach 10 such that a seal resistant tovacuum is created when the balloon is inflated. Resistance to vacuum is,for example, up to a vacuum gauge pressure of about 0.1 bar, 0.2 bar,0.3 bar, 0.4 bar, 0.5 bar, 0.6 bar, or another greater, lesser orintermediate vacuum pressure.

A difference between FIGS. 1F and 1G (also shown straight and extended),and a difference also between corresponding FIGS. 6A and 6C (showingpositioning of a curved bougie within a stomach 10) is the inflation ofballoons 104, 106. In FIGS. 1F and 6A, balloons 104, 106 are deflated.The balloons 104, 106 are inflated in FIGS. 1G and 6B. FIGS. 6A and 6Calso show the position of the bougie relative to features of the stomach10 including the region whereat the gastric sleeve 16 is to be formed,and the outer curve of the stomach whereat a gastric pocket 18, to whichthe entrance of food will be largely restricted, is to be formed. Theboundary between the two regions is according to the partition definedalong approximation line 11 as illustrated in FIGS. 1A-1B. It should beunderstood that the gastric pocket configuration show in FIGS. 1A-1B isexemplary, and not limiting of the forms of gastric reduction to whichembodiments of the current invention are applicable. For example, thefinal pattern, position, and/or length of gastric attachment ispotentially different in different applications of some embodiments ofthe invention, according to the specifics of the procedure.

Some potential advantages of endoluminal gastroplasty as such aredescribed hereinabove, and include, for example, reduced risk ofleakage, lowered invasiveness of the procedure, and/or reduced recoverytime. Potentially, the risk of interruptions to the blood supply ofremaining functional parts of the stomach/pylorus is reduced by avoidingwholesale resection. Optionally or alternatively, electrical blockagesand/or arrhythmias are avoided.

Nevertheless, as an exemplar of the range of possible procedurescontemplated: an initial gastroplastic formation of a gastric sleeveserves as a first phase of a series of procedures leading togastrectomy. Initial gastroplasty is performed all the way betweenesophagus and the pylorus, and follow up of the patency of the resultperformed, for example, by measuring the transfer of a trace materialfrom the sleeve to the isolated pocket. Upon determination, for example,that a good seal has been formed, gastrectomy is performed to remove thepocket region, making the procedure permanent.

In some embodiments an opening to the pocket (e.g., near the pylorus)serves to allow gastric flow out of the pocket and/or avoid interruptionof blood flow, electricity and/or peristaltic waves.

FIG. 6B shows the bougie 100 in bent form without the stomach 10, wherecurve 130 conforms to the curve of the stomach near inner curve 16. Insome embodiments, the bougie 100 is naturally straight (whenunconstrained), and bends to conform to the curve upon insertion. Insome embodiments, bougie 100 is naturally curved (when unconstrained),but can be straightened sufficiently to pass through the esophagus 14and into the stomach 10. Within the stomach, a pre-curved bougie 100tends to re-assume its curved shape, potentially assisting positioning.

At block 164, in some embodiments, the bougie and/or the gastric wallsare manipulated so as to bring the walls into approximation, such that aseam line forms along or about along the rows of fenestrations 108A,108B on body 120 of bougie 100. Optionally, manipulation comprisesapplication of vacuum (for example, to a level of about 0.5 bar gauge,or a greater or lesser vacuum). Optionally, collapse upon application ofvacuum is uniform and symmetric around the bougie, such that the twowalls naturally collapsed to meet in the region of the fenestrationrows. Optionally, a first wall is captured, and then a second wall.Optionally vacuum is turned on and off during capture, as the walls arecoaxed into position (one at a time, simultaneously, or alternately),before a desired configuration is reached.

In some embodiments of the invention, vacuum ports are positioned tohelp guide a process of approximation around the bougie. Bougie 2100 ofFIG. 21A, for example, provides an example of vacuum ports distributedaround the circumference of a bougie, which potentially act to drawgastric wall continuously around the bougie from one side to where thetwo wall parts meet on the other. In some embodiments of bougie 100,such circumferentially distributed vacuum ports are provided.

In some embodiments, the material of at least a portion of bougie 100 istransparent. Optionally, this allows visualization through the bougiebody 120 of the surrounding state of the gastric wall 20. Potentially,this helps guide positioning.

Upon completion of insertion (in the above-described, or another orderof subtasks), one or more of the following has been accomplished:

-   The walls of a future gastric sleeve are defined by the wall    portions which wrap around the bougie.-   The seam along which opposite sleeve walls are to be attached is    defined, and placed about along the line defined by the rows of    fenestrations 108A, 108B.-   Optionally, the gastric compartment is sealed against the entry of    gas, allowing a stable vacuum to be provided.

Furthermore, in some embodiments, gastric wall tissue is pulled and heldto fenestrations 108A, 108B of the bougie 100 by vacuum, but preventedat most or all of the fenestrations from deeply intruding into the lumen40 of bougie 100 by a blocker 102.

Reference is now made to FIGS. 2A-2C, which schematically illustrate theposition of gastric wall tissue around cross sections of a positionedbougie 100 under vacuum, the wall tissue being prevented from free entryto the lumen 40 of the bougie by a blocker 102, according to someexemplary embodiments of the invention.

In some embodiments, blocker 102 comprises a strip extending along thefenestrated length of bougie 100. Optionally, the strip divides two rowsof fenestrations; defining for each a medial limit. The strip is bracedalong the length of the bougie, for example by slots 109 and/or cavitiesthrough which a portion of the strip passes.

FIG. 2A shows the bougie 100 in a straight and extended configurationfor clarity of illustration. FIGS. 2B and 2C show cross-sections 704 and702, respectively. Cross-section 704 is at a level of bougie body 120where there is no open fenestration. Blocker 102 entirely covers any gapin region 111 which might otherwise exist in the bougie 100 at thislevel. Accordingly, gastric wall 20 is not forced into closeapproximation here.

Cross-section 704 is at a level of bougie body 120 where openfenestrations 108A and 108B are found. The two fenestrations areprevented from directly merging at this level by the inter-spacedposition of blocker 102. Due, for example, to vacuum, gastric wall 20comprises intrusions 20A through the fenestrations, but the depth of theprotrusion is shallow enough that lumen 40 remains substantially open.

In FIG. 2B, blocker 102 is shown as bridging a gap in the wall of thebougie body 120. In some embodiments, the wall of the bougie bodycontinuously crosses a region between fenestrations in the same row, andthe blocker 102 passes within or through the wall in these regions.

In some embodiments, the same blocker 102 or another blocking structurecomprises regions which run along the lateral boundaries of thefenestration rows, limiting fenestration width. Optionally, a blockerportion comprises portions that reduce fenestration size as measuredalong the length of the bougie 100. In an example including blockingarrangements for restricting the size of each side of the fenestrations,a sliding blocker comprises three long vertical strips, cross-linked byhorizontal strips at intervals corresponding to the period of thefenestrations.

A second lumen 106A contained within the sidewall of bougie body 120 isalso shown in FIGS. 2B and 2C. In some embodiments, this comprises aninflation fluid conduit leading to balloon 106.

Reference is now made to FIG. 5 , which schematically illustrates theconfiguration of inflatable bougie anchoring balloons 104, 106 and theirinflation lumens 104A, 106A, according to some exemplary embodiments ofthe invention.

In some embodiments, the inflation states of balloons 104, 106 aremanaged by the movement of an inflation fluid (gas such as air or CO₂;or liquid such as saline) through their respective inflation fluidconduits 104A, 106A. Optionally, a single conduit serves both balloons.In some embodiments, balloons 104, 106 comprise flexible (optionally,elastic) membranes attached to the body 120 of a bougie 100, forexample, around rings 105.

Suturing the Gastric Sleeve

Reference is now made to FIG. 1E, which is a schematic flowchart of aprocess of suturing gastric walls together using a bougie 100, accordingto some exemplary embodiments of the invention.

It is envisioned that several variations of the suturing procedure areenabled by embodiments of the present invention. In some cases, multiplevariations can be carried out by various use of a single embodiment.Optionally, variation is within a single procedure. In some cases,variations are carried out by different embodiments of the invention.Variably carried-out operations are indicated in FIG. 1E by the use ofdotted-line bypasses, and round-cornered blocks, where appropriate. Alsowhere appropriate, it should be understood that other orders ofoperations, reversals, and repetitions are to be carried out asnecessary during an actual surgical procedure.

In some embodiments, suturing is with surgical suture thread and needle,performed under endoscopic guidance. Optionally, the suture used is abarbed or “knotless” suture. In some embodiments, suturing is performedwith the use of an automatic or semi-automatic suturing device.

After insertion and positioning of bougie 100, at block 170, in someembodiments, secondary stabilization optionally occurs. In someembodiments, (particularly for example, if it is found to be difficultto sealingly secure one or both of balloons 104, 106, due, for example,to irregularities of the patient anatomy), vacuum stabilization isimmediately supplemented with another stabilizing method. Optionally,for example, barbed suture is passed between the two gastric wallsections at one or more places along the body 120 of the bougie 100,regardless of whether or not the more stable muscle layers aresurgically accessible at this stage.

Reference is now made to FIG. 4C, which schematically illustratespenetration by a needle 33 under the control of a needle holder 35 intosuperficial regions 24A of gastric wall tissue, according to someexemplary embodiments of the invention. In some embodiments, motions ofthe needle and/or needle holder are monitored under visualization, forexample, endoscopically or radiographically monitored. Optionally, thebougie is provided with one or more radioopaque markers, for example,near fenestrations thereof, at its ends and/or in the sealing balloons(if any).

In some embodiments, this relatively insecure form of suturing is usedto provide (optionally temporary) stability against fluctuations invacuum, either accidental, or during position adjustment. Potentially,such sutures are relative fast and easy to perform; since, for example:there is relatively free maneuvering room (less tissue filling) withinthe lumen 40 bougie body 120, the tissue 24A to be penetrated isrelatively less tough than the more muscular deep layers 22A, and/orbecause the depth of penetration required is relatively low. Optionally,only a portion of the suture points which will be finally secured areattached with stabilizing sutures. It should be noted that thestabilization comes from suturing blocker 102 to the tissue. The abilityto later slide the blocker out of position prevents this from becoming apermanent situation.

Alternatively or additionally, secondary stabilization comprises one ormore pins driven horizontally or vertically through short tissueintrusions into the bougie lumen. For example, a pin is drivenvertically down one or both rows of tissue intrusions. Additionally oralternatively, tissue intrusions are stabilized by horizontally arrangedpiercing needles. For the speed of the procedure, it is a potentialadvantage to operate such piercing needles as a unit. For example, a rowof arc-shaped needles is optionally mounted on a common drivingmechanism (such as a shaft or partial tube), allowing them to be drivenaround the inner circumference of the bougie to skewer tissue intrusionsfrom the side. Optionally, secondary stabilizations are individuallycontrollable, and in particular, individually removable as needed; forexample: by removal of a vertical pin one intrusion at a time, or, forexample, by removal of horizontal piercing needles one needle at a time.Other examples of secondary stabilization means include helical inserts(corkscrews that screw into the gastric wall) and/or clamps.

Secondary stabilization means of whatever type are optionally applied,for example, in the case where it is found necessary to reduce vacuumand/or readjust the wall positions in another portion of the bougie. Ingeneral, however, it has been observed by the inventors that goodinitial positioning of the stomach walls within the fenestration rows ofthe bougie under vacuum can be readily achieved, and that thestabilization of vacuum provided by the balloons allows suturing to becompleted without a need for readjustment or reliance on secondarystabilization.

At block 171, in some embodiments, blocker 102 is (optionally) partiallypulled in a proximal direction from its previous blocking position.Optionally, blocker 102 is pulled far enough to merge one pair offenestrations 108A, 108B into a single merged fenestration 110.Optionally, movement of blocker 102 otherwise opens the fenestrationsfor the admission of additional gastric wall tissue. For example, movingthe blocker removes constraints on the fenestration size from thelateral sides, top, and/or bottom of the fenestrations. Additionally oralternatively, the blocker masks a thinner medial portion (part of thebougie wall, or another moveable blocker); such that the fenestrations108A, 108B remain separate, while admitting additional tissue (forexample, under the force of vacuum pressure).

Reference is now made to FIGS. 1H-1I, which schematically illustratebougie 100 with blocker 102 partially withdrawn to merge a portion ofits paired fenestration rows, according to some exemplary embodiments ofthe invention. FIG. 1I shows magnified versions of several of the samedetails as FIG. 1H, with intervening sections elided. Also, FIG. 1Ishows the terminal end 102B of blocker 102 in a different positionrelative to a partially unblocked fenestration 108C than is shown inFIG. 1H.

In some embodiments, blocking portion 102A of blocker 102 separates rowsof fenestrations 108A, 108B until it is at least partially withdrawnproximally via the proximal end 122 of the bougie 100. Distal blockerend 102B of blocker 102 marks the most distal point which remains fullyseparated. In some embodiments, withdrawal of blocker 102 merges thefenestration rows, one pair at a time, to form merged fenestrations 110.In some embodiments, withdrawal also exposes a region 111 whichcomprises a gap connecting fenestrations adjacent along the length ofthe bougie body 120. Alternatively, region 111 comprises a bridgingportion across bougie body 120, which blocker 102 crosses, but does notopen when it is withdrawn.

In some embodiments, the widths (around the circumference), heights(along the length), and intervals of and/or between (unblocked)fenestrations are about 1 cm. Such distances provide about a 2 cmsuturing pitch, which provides a reasonable balance between preventingsubstantial leakage across the gastric sleeve to the semi-isolatedgastric pocket, and avoiding a need for making an excessive number ofsuturing passes through the tissue, extending the length and/ordifficulty of the procedure. In some cases a different stitch pitch isprovided, for example, between 0.8 and 2 cm, for example, about 1 cm or1.2 cm.

In an exemplary embodiment of the invention, each fenestration receivesa single pitch. In some embodiments, two or more stitches may beprovided for at least some fenestrations. In some embodiments, thestitches are tight, for example, to prevent leakage and/or encouragetissue adhesion. Optionally, a tissue adhesion material is providedbetween the stomach walls, for example, by elution or injection viablocker 102. Optionally or alternatively, an adhesive encouragingelement, such as a mesh is implanted between the stomach walls, forexample, being originally mounted on blocker 102 and more tightly heldby the sutures than blocker 102, so it can separate therefrom.

In an exemplary embodiment of the invention, if there is no penetrationof stomach outer layer, some leakage into the pocket, for example, ofbetween 10% and 40% (or more) of the food entering the sleeve may betolerated. In other embodiments, it is desired that at least between ethstitches leakage is less than, for example, 10%, 5% or 1% and thestitches are pitched closely enough together and/or tightly enough.

Blocked, the fenestration widths are reduced, for example, to about 3mm, with the blocker 102 being about 3 mm wide. These can be related totypical gastric wall thicknesses (single thickness) of 2-5 mm. In somehealthy patients, gastric wall thicknesses up to about 7 mm arereported. Still thicker gastric wall thicknesses can occur, for example,in a stomach having neoplasia, and/or a stomach where full distensionhas not been achieved. In some embodiments, portions of up to 4 wallthicknesses (two walls, each partially doubled over) are drawn to thebougie for their mutual attachment. It should also be understood thatother dimensions compatible with the surgical conditions of tubeinsertion to the stomach through the esophagus are possible, includingdimensions which are different for each of these measurements, and/oramong different fenestrations. Dimensions of fenestrations of variousembodiments are also described, for example, in relation to FIGS.10A-10H hereinbelow.

Reference is now made to FIG. 3A, which schematically illustrates thevacuum invagination of gastric wall tissue to a bougie 100 withintrusion-limiting fenestrations, according to some exemplaryembodiments of the invention. Reference is also made to FIG. 3B, whichschematically illustrates the further invagination of gastric walltissue 20 into a bougie 100 upon removal of blocker 102 while vacuumcontinues to be applied, according to some exemplary embodiments of theinvention. Considered sequentially, FIGS. 3A-3B illustrate the effectson tissue position within a cross-section of bougie lumen 40 upon thewithdrawal of blocker 102 from a pair of fenestrations 108A, 108B.

In FIG. 3A, the two opposing portions 29A, 29B of gastric wall 20 areshown drawn around the body 120 of a bougie 100, for example as they arepositioned after proper positioning of the bougie for beginningsuturing. With vacuum applied to the bougie, portions 26 of the moresuperficial gastric wall layers 24 are drawn into bougie lumen 40. Thesuperficial layer 24 includes, for example, portions of the mucosaand/or submucosa. Because the fenestrations 108A, 108B are relativelynarrow in at least one dimension, the amount of tissue drawn isrelatively small, and lumen 40 remains relatively open.

However, upon withdrawal of blocker 102, a wider merged fenestration 110is formed (FIG. 3B). Portions 26 are then able to invaginate more fullyinto the lumen 40 of the bougie body 120. This results in the deeperlayers 22 of the gastric wall 20 becoming more accessible from the sideof the lumen. Optionally, the deeper layers comprise, for example, themuscular layers of the gastric wall. The muscular layers are, in someembodiments, a preferred target for suturing due to greater toughness insupporting sutures. It can be understood that another change whichwidens fenestrations 108A, 108B would also allow the admission ofadditional tissue for suturing. For example, in some embodiments,widening of the fenestrations comprises removal of a laterally situatedblocker and/or blocking which is above and/or below the plane of theFIG. 3B. Likewise, merging of fenestrations 108A, 108B to a singlefenestration 110 is a feature of some but not all embodiments of theinvention. Merging fenestrations confers the potential advantage ofallowing opposite walls to be sutured together without suturing theframe of the bougie itself into place. Another potential advantage issimply that the blocker 102 is removed from a position where it couldinterfere with the act of suturing.

Nevertheless, it is possible, in some embodiments, to leave blocker 102in place at this stage of the suturing, and remove it (freeing thebougie) at a later stage, for example as described in relation to block176.

At block 172, in some embodiments, the position and/or stabilization ofthe bougie is optionally adjusted. In some embodiments, the gastricwalls are fully positioned before suturing begins (for example, at block164), and vacuum is maintained fully throughout the suturing procedure.Potentially, this configuration is sufficiently stable that noadditional position adjustment is required. In some embodiments, initialconfiguration comprises grabbing and positioning only a portion of theeventual line of approximation, so that movement of blocker 102 changesthe tissue which is available to be secured. In some embodiments, aregion of wall newly exposed to vacuum is adjusted into place, forexample by iterative raising and lowering of vacuum, coaxing motions(wigging) of the bougie, or another method.

At block 173, in some embodiments, suturing of the next site of tissueintrusion along the bougie 100 is performed.

Reference is now made to FIGS. 4A-4B, which schematically illustratealternative suturing situations, according to some exemplary embodimentsof the invention. Reference is also made to FIGS. 4D-4E, whichschematically illustrate cutaway side-views of suturing from withinbougie 100, according to some exemplary embodiments of the invention.Further reference is made to FIGS. 4F-4G, which schematically illustratethe potential for interference of proximal tissue intrusions on thesuturing of more distal tissue intrusions within bougie 100, accordingto some exemplary embodiments of the invention. Reference also is madeto FIG. 4H, which schematically illustrates suturing at a level of thebougie with a blocker in place, according to some exemplary embodimentsof the invention.

In some embodiments of the invention, it is a potential advantage tosuture sites beginning from the distal portion of the bougie and workingmore proximally from site to site. Proximally-directed removal ofblocker 102 causes distal sites to deeply invaginate first, while moreproximal sites continue to be restrained from intrusion to the lumen 40.If all sites were deeply invaginated to the lumen 40 from the beginningof the procedure, it would be potentially more difficult to reach thedistal end of the bougie. In FIG. 4B, in some embodiments, a situationof suturing to a site of a removed blocker is schematically illustrated.The needle holder 35 is shown passing a needle 32 into the deep(muscular) layers 22A of the gastric wall, in a portion of lumen 40which is largely filled by involuting tissue. An advantage of suturingin this configuration is the relatively high exposure of the muscularlayer 22A. Potentially, the disadvantage of restricted space at thecross-section of the fenestration itself is overcome by suturing from anout of plane angle.

In some embodiments, however, blocker 102 is left substantially in placeduring suturing. Optionally, it removed instead after suturing, forexample, at the end of the procedure. FIG. 4A illustrates suturing forthis alternative form of the procedure. In this case, the exposure ofthe muscular tissue is potentially lower. As illustrated, the needleneeds to pass substantially outside lumen 40 in order to reach thetargeted muscle layer 22A. Potentially, this requires using a somewhatlarger radius and/or longer needle 31, which potentially creates adifferent form of spatial restriction on the range of motions availablefor suturing. Needle 31 is also shown at an out-of-plane position 31A,which can potentially overcome such a spatial restriction.

FIG. 4H illustrates another suturing situation which blocker 102 remainsin place until after placement of the suture, and suturing occurs withinlumen 40 of a bougie body 120. In some embodiments, blocker 102 andfenestrations 108A, 108B are sized such that a portion of target tissuelayer 22A is admitted to lumen 40 upon application of suction. In someembodiments, this allows needle holder 35 to pass needle 32 through thetarget layer, effectively sewing-in the bougie body 120 until bougieblocker 102 is removed, for example by sliding proximally along thelongitudinal axis of the bougie until the suture region is freed.

In some embodiments, another form of blocker which allows post-suturefreeing comprises a blocker having a longitudinal body, locatedalongside the fenestrations, and along which “L” shaped projections areattached at intervals corresponding, for example, to the fenestrationperiod. The horizontal bars of the “L” shapes of the blocker projectbetween fenestrations, while the rising bars of the “L” shapes projectlongitudinally between the fenestrations (in either longitudinaldirection; or if in both, the shape is a sideways “T”). A sufficient gapis optionally left between each projection to allow release of a sutureand/or of sutured tissue as the gap passes across it. Release, in suchembodiments, comprises moving the blocker proximally or distally(depending on the orientation of the “L”) for a sufficient fraction ofthe inter-fenestration space that release occurs. This potentiallyallows simultaneous release of sutured-in fenestrations. Potentially,this allows simultaneous adjustment of the penetration depth of thetissue along the length of the bougie, since, as the gap crosses overthe fenestration region, the deepest penetration achieved by the tissuealong the fenestration is liable to increase.

In some embodiments of the invention, the L- or T-projection blocker isrotatable around the axis of the bougie. Optionally, this motion is usedduring capture of the gastric walls. Optionally, the blocker is firstrotated to move the vertically projecting bars into place over one ofthe sets of fenestrations, ensuring that all tissue captured during anapproach to one of the walls falls onto a single side of thefenestration rows. Upon sufficient capture of the first wall, the barsare rotated toward the middle to push the captured wall out of the way,and the second wall sought and captured.

FIGS. 4D-4E show views from orthogonal angles of a needle 34 beinginserted through intruding gastric wall tissue layers 24A, 22A.

In some embodiments of the invention, suturing is by means of anautomated or semi-automated stitching device, for example, a devicemounted at the end of an endoscope. Such a device and/or the endoscopetip on which it is mounted typically occupies a 1 cm diameter cylinderor larger. Potentially, this largely fills the bougie lumen 40, leavinglittle space for maneuvering. In some suturing devices, moreover, thereis a distally protruding part, and a more proximal part, between whichtissue to be sutured must be positioned. In such embodiments, it is apotential advantage to move the suturing device into position beforewithdrawing the blocker, allowing tissue to infill between the distallyprotruding part and the more proximal part, so that suturing can occur.FIG. 10C illustrates an embodiment potentially useful in such asituation, where fenestrations 1002A, 1002B of the two rows(corresponding to the two walls) are alternately arranged (mutuallyoffset by a distance 1009) along the bougie length. Thus offset, theycan be alternately opened as a blocker 102 is withdrawn, allowing thesuturing device to be moved into position for one tissue protrusion at atime, and for each such protrusion.

In FIGS. 4F-4G, a relatively thin needle holder 35 is shown attemptingto insert a needle 34 into a tissue protrusion comprising tissue layers22A, 24A.

More distal protrusions 20B of FIG. 4F fill lumen 40 sufficiently tointerfere visualization and/or positioning of needle 34 and/or needleholder 35. More distal protrusions 20C of FIG. 4G, however, remainrestrained by a blocker 102, permitting more freedom of visualizationand/or positioning of needle 34 and/or needle holder 35.

Reference is now made to FIG. 12E, which is a schematic perspectiveillustration of a fenestrated bougie 100, wherein suturing by a needle32 held by a holder 35 is carried out under observation by an endoscope41, according to some exemplary embodiments of the invention.

FIG. 12E shows an exemplary instance of constraints within a bougie 100during operations for suturing a gastric sleeve. A section of tissue 20is shown wrapped around the body of the bougie 120, with fenestrations108A, 108B separated by a blocker 102. Needle holder 35 and endoscope 41are inserted in parallel to the bougie 100, and separately operated toallow suturing under visual observation.

In some embodiments, a separate needle holder 35 is omitted, and anattachment assisting apparatus (such as an automatic suturing orstapling device) is attached to the end of endoscope 41 and used forforming attachments between opposite gastric wall portions.

Reference is now made to FIG. 12F, which is schematic cross section of abougie body 120, having a slot region 43 for assisting positioning of aneedle 32, according to some exemplary embodiments of the invention.

In some embodiments of the invention, the lumen 40 of bougie body 120comprises one or more partial rings 42, each ring 42 comprising a slotregion 43 sized for the passage of a needle holder 35 thereinto (e.g.,from a longitudinal direction), and therealong (e.g., around thecircumference of the bougie). Optionally, the central region of lumen 40is left open, for example allow passage of an observation devicetherethrough. Optionally slot region 43 enforces guidance of themovement of needle holder 35, such that the needle 32 is passed into thetargeted level of tissue 20.

Returning now to FIG. 1E, at block 174, in some embodiments, adetermination is made as to whether or not the last site has beensutured. If not, flow continues, in some embodiments, at block 171.Alternatively, flow returns to block 172 for adjustment of secondarystabilization, or directly to suturing of the next site.

Otherwise, optionally at block 176, the blocker 102 is withdrawn, if ithas not been withdrawn during the previous course of suturing. In someembodiments, this frees bougie 100 from suturing-in that has occurredaround a blocker left in place during the surgery. At block 178, in someembodiments, the bougie is withdrawn, including, for example, release ofvacuum, any maneuvering of the bougie required to release it fromsutures and/or remaining intrusions by the wall, and/or deflation ofanchoring balloons 104, 106.

At block 180, in some embodiments, finalization of the gastric sleeve isperformed. This can include, for example, final tightening of sutures,inspection of the results, and/or supplementary suturing as required(the sleeve itself having already been substantially formed).Supplementary suturing is optionally performed, for example, to reducegaps of excessive size which may be noted between sutures (which mightallow food to pass), and/or to extend the sleeve section to reach closerto an end of the stomach (the end of pylorus or the esophagus). Here thedescription of the flow chart of FIG. 1E ends.

Blocker and Fenestration Features and Parameters

Reference is now made to FIGS. 7A-7D, which schematically illustrate abougie 300 configured with a blocker slider 302 shaped to allow bothfull and partial blockage of positioning/suture fenestrations 108A,108B, 110, according to some exemplary embodiments of the invention.Reference is also made to FIGS. 7E-7F, which schematically illustrateperspective and perspective detail views of bougie 300, according tosome exemplary embodiments of the invention. FIG. 7F shows a detailedview of region 140 of bougie 300 of FIG. 7E.

In some embodiments, a bougie 300 comprises a blocker 302 extendingthrough a portion of bougie body 320, wherein the blocker 302 ispositionable to block one or more fenestrations 308 entirely.

In some embodiments, blocker 302 extends laterally, for a portion 302Aof its length, across a sufficient lateral arc of the circumference ofthe bougie 300 to block the whole width of fenestrations 108A, 108B.Optionally, the blocker 302 comprises through a part of this length awhole tube that fits within or around bougie 300. In some embodiments,when blocker 302 is not an entire tube, a slot 109A is provided ofsufficient width to hold the wide blocker 302.

In some embodiments, blocker 302 comprises a thin section 302C, which issufficiently narrow that fenestrations 108A 108B are partially open whensection 302C is positioned (for example, by proximal withdrawal ofblocker 302) at their level along the length of the bougie 300. In someembodiments, being partially open allows suction of gastric wall tissue20 into the fenestrations 108A 108B for stabilization, without deepintrusion that interferes with suturing activity. In some embodiments,further withdrawal of the distal end 302B of blocker 302 past afenestration pair 108A, 108B allows the fenestrations to merge to asingle fenestration 110.

In some embodiments, variation of fenestration exposure is controlled bymotion of a blocker (102, 302, or another blocker) along thedistal-proximal axis. Additionally or alternatively, rotation of ablocker changes fenestration exposure. For example, a tube-like blockeroptionally comprises an open region with at least one diagonallyoriented (helical) side. The degree and/or position of fenestrationopening is then controllable at least in part by the rotational positionof the blocker.

Reference is now made to FIGS. 7G-7J, which schematically illustrate abougie 350 comprising a blocker 352 for which the size and/or positionof the blocking region is controlled by helical motion, according tosome exemplary embodiments of the invention.

In some embodiments, a blocker 352 comprises at least one blockerportion 355 having a helical slit 358. According to the pitch and widthof the slit 358, as blocker portion 355 is rotated (for example indirection 357), the region which faces the fenestrations 351 of thebougie 350 moves along the length of the bougie. In this fashion, abougie fenestration 351 can be moved to become a fully open fenestration365 or a partially open fenestration 367, according to the size andposition of opening 362. Optionally, a second blocker portion 356 havingan opening 360 is used, which optionally comprises a pitch and/or widthdifferent than that of opening 358. In some embodiments, the pitches runin opposite directions, allowing the definition of a clear hole 362between them which can be controlled to move along the length of thebougie 350 according to rotations with or against the directions ofarrows 357, 359. Additionally or alternatively, the exposure of opening362 to the bougie fenestrations 351 is made larger or smaller bydifferent relative motions of the blocker portions 355, 356.

A potential advantage of this method of controlling fenestration openingis to allow gradual movement of gastric wall tissue 20 in and out ofselected bougie fenestrations 351, according to the current position ofthe working region. Optionally, the two blocker portions 355, 356 areworked against each other and/or the walls of the fenestrationsthemselves in order to pinch gastric wall tissue 20 into place.Additionally or alternatively, the blocker portions 355, 356 can berotated to “lever” tissue out of the bougie. Optionally, the ability toset the lateral size of the bougie fenestration opening is used todynamically adjust to the conditions of the tissue wall - for example,opening a larger fenestration where the muscle layer is buried under athicker layer of mucosa/submucosa, and/or a thinner fenestration wherethere is more danger of penetrating the wall entirely.

It is to be understood that the helical slots shown need not haveperfectly helical edges; optionally, the walls comprise indentations,for example, to better match the shapes of the fenestrations.Additionally or alternatively, by adding horizontal protrusions ofblocker material across the slots 358, 360, for example, regions whichare never unblocked are defined in some embodiments.

Furthermore, it can be understood that blockers having a “slider”configuration (such as blocker 102), are optionally used together withone or more rotating slot blockers. A vertically slotted blocker, forexample, is provided in some embodiments, and optionally rotated todifferentially control the penetration depth of one of the two gastricwalls relative to the other.

In general, it should be understood that blockers can be provided asmore or less tube-like or strip like, in nested and/or adjoining sets,with the slotting and/or width of each blocker portion set to the shapesof the same or different “masks”, such that a required type and/orspecificity of control over the localization, depth, and extent ofgastric wall tissue penetration into the bougie is obtained.Potentially, the provision of greater control allows a practitionergreater ability to adjust suturing depth to patient-and region-specificvariations in conditions like gastric wall thickness. On the other hand,in some embodiments, a simpler blocker configuration is chosen, such asonly a single blocker, to obtain maximal maneuvering room, efficiency ofoperation, reproducibility, or another factor.

Reference is now made to FIGS. 8A-8B, which schematically illustrate abougie 400 comprising fenestrations wherein depth of tissue penetrationis adjusted by regions of varied wall thickness, according to someexemplary embodiments of the invention. FIG. 8B illustrates across-section from region 440 of bougie 400. Reference is also made toFIGS. 9A-9B, which schematically illustrate a bougie 500 comprisingfenestrations wherein depth of tissue penetration is adjusted by regionsof varied wall thickness, according to some exemplary embodiments of theinvention FIG. 9B illustrates a cross-section from region 540 of bougie500.

In some embodiments, the dimensions of the material defining thefenestrations of the bougie is configured to select the depth of tissuepenetration. In FIG. 8A, a bougie 400 is shown having raised regions 442along its length. The raised regions tend to increase the wall thickness443 around the fenestration, such that a lesser thickness of gastricwall 20 is exposed to suturing. In particular, a depth of tissueintrusion in the region between suturing fenestrations is reduced, whilemaintaining the power to participate in vacuum fixation. The raisedportion 442 of the wall adds, for example, 1 mm, 2 mm, 3 mm, or anothergreater, lesser, or intermediate thickness to the wall portion adjoininga fenestration 444. In some embodiments, the thickened wall allowsproviding greater support to a blocker 402, for example by allowing alarger and/or more robust slot 446 to be cut into the wall at thatpoint. This is a potential advantage for a bougie which needs towithstand, for example, about 0.5 bar gauge of vacuum pressure.

In FIGS. 9A-8B, the raised sections 542 extend for a greater distanceround the circumference of the bougie, showing another shape which ispossible. Another option is to change the height of the raised sectionsat various positions along the bougie; for example, such that lesspenetration is allowed at portions of the stomach wall which arethinner, and thus more liable to accidental penetration by a needle.FIG. 9B also shows again the relative depth of tissue penetration into abougie. The relatively thick rings 542 (the thickness being defined, forexample, by wall edge 544 and/or by thicker regions near the middle ofthe ring) potentially allow the intervening portions 546 to be builtrelatively thinner, and still be sufficiently able to stand the vacuumpressure. This potentially allows greater room for maneuvering at thelevel of the suturing area and/or allows greater exposure of musclelayer 22, without requiring correspondingly deeper penetration of themucosal/submucosal layer 24 and the inner surface 26.

In some embodiments, slope 543 is adjusted so that the tissue slopinginward from the point of maximum stand-off of protrusion 542 is guidedto an angle allowing the best penetration across the length of thefenestration 508.

Reference is now made to FIGS. 10A-10M, which schematically illustratedifferent dimensions and shapes of fenestrations and supporting wall,having different effects on function, according to some exemplaryembodiments of the invention.

In general the fenestrations 108A, 108B, related to as comprising tworows, can also be considered as a single row of fenestrations 110separated by a blocker 102. FIG. 10A illustrates this by labeling twofenestration halves 1000A, 1000B, above another fenestration labeledoverall as 1000. Fenestrations 1000 are optionally joined by a thinnerregion 1000C; in the limit, region 1000C is so thin that it disappears,and the fenestrations are entirely separate. Dimensions affecting theserelationships include:

-   overall fenestration width 1003 (which is, for example, 8-10 mm,    9-13 mm, 11-15 mm, 14-17 mm, or another greater, larger, or    intermediate width);-   joining region width 1004 (which is, for example, 0 mm, 1-2 mm, 2-4    mm, 3-5 mm, or another greater, larger, or intermediate width);-   joining region length 1006 (which is, for example, 8-10 mm, 9-13 mm,    11-15 mm, 14-17 mm, or another greater, larger, or intermediate    width);-   and fenestration length 1005 (which is, for example, 8-10 mm, 9-13    mm, 11-15 mm, 14-17 mm, or another greater, larger, or intermediate    width).

One possible consideration constraining the period between fenestrationsis the interval for suturing. In a gastric sleeve where a non-fillingpocket is to be retained afterward, the sutures need be close enoughtogether to prevent the passage of stomach contents, such that thesleeve forms a distinct compartment. A spacing of about 2 cm isgenerally sufficient to ensure this, though a different spacing is alsoused in some embodiments: for example, 1-1.3 cm, 1.3-1.5 cm, 1.5-2.5 cm,2.3-3.0 cm, or another larger, smaller, or intermediate suture spacing.The distance chosen determines the sum of the distances 1005 and 1006.

As already described, a main consideration affecting the maximum size ofa fenestration opening is the thickness of the tissue to be passedthrough by a suturing needle. Preferably, at least 3-5 mm of tissue areadmitted to the bougie lumen, to allow the muscular layer to pass beyondthe boundary of the bougie’s inner wall. The wall itself may be 2-3 mmor more thick, adding to the thickness that must be admitted beyond theouter diameter of the bougie. Nevertheless, not much more tissue thanthis should be admitted, to avoid the danger of running a sutureentirely out of the gastric wall, and potentially inducing a gastricleak.

Two doubled-over gastric walls comprise a typical thickness in the rangeof 12-20 mm (at least where they are sharply folded). A long enoughfenestration which was at least that wide would potentially be able toadmit tissue all the way to the other side of the bougie. This would, ingeneral, be too much tissue, as it would potentially bring the outersurface of the gastric wall within the bougie. The bougie outer diameteritself is limited to about 20 mm (11-20 mm is a typical range), in orderto pass the esophagus. Nevertheless, a maximally open 20 mm bougiehaving a wall thickness 1013 of 2 mm would fall right on the edge of therange that could admit the whole doubled-over thicknesses of the wall.It is preferably provided, in some embodiments, for the fenestrationheight 1005 to be small enough (for example, 8-10 mm, 9-12 mm, 11-14 mm,or another larger or smaller height) that the desired penetration rangeis not exceeded. In some embodiments, the fenestration is additionallyor alternatively narrowed, allowing the curve of the bougie to decreasethe admission aperture of the fenestration on each side by a distance1012.

So long as sufficient tissue is admitted to the bougie, there is apotential advantage to admitting tissue to the bougie with a sharpangle, such that a needle is faced with a sharp “cliff” of tissue,rather than a gradual rise. During suturing, the needle itself, thoughitself quite thin, tends to be only a short distance in advance of athicker holding means, which is more limited in maneuvering space. Inview of this, the “cliff” is potentially most important on the side ofthe fenestration from which the needle approaches. However, subjectingthe tissue to sharp bends also potentially reduces the tendency of thetissue to slide around, since it must pass through a sharper bend to doso.

Nevertheless, the acute angle that wall 1011 or 1031 makes with theouter diameter of the bougie tends to create a sharp edge 1010 or 1030which is a potential source of unnecessary injury due to the level ofvacuum pressure pulling on the gastric wall. In some embodiments, arounded edge 1020, 1050 is instead provided, which potentially softensaccess to even a sharp-angling wall like wall 1021. Acute edges can alsobe reduced by changing the slope which the exposed wall 1040 makes withthe circumference of the bougie. This can potentially also have theeffect of changing the apparent thickness of the wall edge 1041.

In some embodiments, the change in slope also is used to control theamount of tissue admitted; for example, for the same distance 1012, amore acute external angle will potentially tend to exclude more tissue,but the tissue which does enter the bougie will potentially tend to doso in a more parallel configuration. It can, conversely, be understoodthat a more deeply chamfered edge potentially allows deeper penetrationof tissue into the bougie lumen. The effect of the cutaway regions onbougie wall strength should also be taken into account, since the morewall material that is removed from the ideal “complete” shape, the moreliable the wall is to collapse under vacuum.

A sharp fenestration corner is in general too confined to have a greateffect on the admission of tissue, but also comprises a potential sourceof unwarranted injury. In some embodiments of the invention,fenestration corners 1007A, 1007B, 1007C, 1007D are rounded (with aradius of curvature of, for example, about 1 mm, 2 mm, 3 mm, or anotherlarger, smaller, or intermediate radius). Optionally, the curves aredifferent at different corners. For example, rounding can be greater onthe edge away from the suturing tools, since a softer curve there isless likely to result in hindrance of access.

In some embodiments, the two fenestration halves are staggered from oneanother along the length of the bougie. The staggering distance isoptionally any fraction of the fenestration period. A potentialadvantage of staggering the rows is to allow alternate exposure of leftand right sides. Potentially, this leaves more maneuvering room at eachlevel. In the case where a suturing machine is used, it can be useful tostagger, to allow more certainty that each wall side is being grabbed inalternation, and, where necessary, that the suturing device is properlyfit around the tissue intrusion for suturing. The period of suturing(determined by the sum of the distances 1008A, 1008B) is variable, forexample, as described in relation to the period determined by the sum ofdistances 1005, 1006.

Using an offset which is smaller than 50% of the period (for example,30%, 40%, or another larger, smaller, or intermediate offset) has thepotential advantage of easing the task of cinching the walls togetherafter suturing is finished. For example, less relative motion isrequired, in such a case, to achieve the tightest suture closure.

In some embodiments of the invention, the slope leading from the outerwall of the bougie to the inner wall of the bougie, which is defined bythe walls of the fenestrations running perpendicular to the bougielongitudinal axis, is selected according to one or more functionalconsiderations.

For a reference embodiment, the slope can be considered as runningperpendicular to the transverse plane of the bougie. If the slope of themore proximal fenestration wall runs distal-to-proximal (e.g., outer toinner), and/or if the slope of the more distal fenestration wall runsproximal to distal, the effect is of a more open interior, whichpotentially helps to promote access to tissue.

The more open interior is also potentially more difficult to forcetissue out of. Potentially, open-inward fenestration walls allow thetissue more room to expand, and thus become lodged. This is a potentialadvantage for stability, and particularly so if a shearing or pinchingforce can be brought to bear (for example, by pulling and/or rotating ona blocker element). On the other hand, in some embodiments, it ispotentially beneficial to allow tissue to be more easily coaxed out ofthe fenestrations. For example, an embodiment where a restricted windowmoves along the length of the bougie must be able to effectively pushtissue back out of the fenestration in order to move more proximally. Insome embodiments, the slope of one or both of the fenestration wallsrunning perpendicular to the bougie length is set so that thefenestration becomes larger toward the outside of the bougie wall, whichpotentially assists this. In some embodiments, the slopes run inparallel directions, such that pressure from one side tends to result in“pinching”, while pressure from the other side tends to result inelevation and extraction.

Reference is now made to FIGS. 11A-11C, which schematically illustratebougies 1100, 1110, 1120 having variable width, variable fenestrationdimensions, and/or variable blocker dimensions, according to someexemplary embodiments of the invention. It is to be understood that thehorizontal and vertical dimensions are not necessarily shown to scale,in order to illustrate differences more clearly.

In some embodiments of the invention, a diameter of a bougie body 1101is variable from a distal to a proximal direction, sloping wider througha region 1109B, for example, from a smaller diameter at distal end 1104to a wider diameter. For a fixed fenestration size and position, thiswould potentially allow templating of a gastric sleeve with a largerlumen near the esophagus, narrowing distally. However, in the exampleshown, distal fenestrations 1106 are narrower in their maximum widththan proximal fenestrations 1108. Potentially, this results in thecircumference of the gastric tube being maintained as roughly equivalentalong the tube, once sutures are cinched tight at the end of theprocedure. It is to be understood that other intermediate results canoccur, depending on the relative change in bougie diameter andfenestration width.

A potential advantage of this variability is to allow the bougie to beadapted to a typical anatomically observed situation, wherein gastricwall tissue near to the esophagus/cardia is relatively thick, growingthinner nearing the region of the pylorus. Furthermore, gastric wallconvolutions are potentially deeper near regions of thickermucosa/submucosa. By providing fenestrations adapted to thisvariability, a potential advantage is derived wherein the balancebetween deep-enough suturing (to reach muscle) and not-too-deep suturing(to avoid wall perforation) is separately selectable for each region ofthe gastric wall.

In some embodiments, blocker 1102 is also adapted to variations inwidth. For example, the blocker 1102 widens as the bougie/fenestrationswiden, so that tissue intrusion is prevented to a similar degree alongthe bougie length. For example, the blocker region 1109A comprises aregion of expanding blocker width.

Maximum differences in bougie width in general fall within the boundsset by a typical 11-20 mm bougie diameter. In some embodiments,variability falls within 1-9 mm of bougie outer diameter, or, forexample, 1-3 mm, 2-4 mm, 3-6 mm, or another range of variability havingthe same, larger, smaller, and/or intermediate bounds. While width isshown in FIG. 11A as the particular fenestration dimension which varies,it should be understood that any of the fenestration dimensionsdescribed, for example, in relation to FIGS. 10A-10M, could also bevaried as a function of length along the bougie.

Optionally, the variability of dimensions is in only one or two of theaspects of fenestration size, blocker size, and bougie body size. Forexample in FIG. 11B, the outer diameter of bougie body 1111 is constant.Proximal fenestrations 1118 are larger (wider, in the example) thandistal fenestrations 1116. Region 1120 of blocker 1112 marks a region ofblocker width transitioning from narrow near the distal fenestrations towider near the proximal fenestrations. Optionally, only one of theaspects changes. For example, in FIG. 11C, blocker 1122 and bougie body1129 have fixed widths, while proximal fenestrations 1128 are wider thandistal fenestrations 1126, the fenestration width being showntransitioning progressively at, for example, fenestrations 1124 and1125.

Reference is now made to FIGS. 11D-11G, which show alternativearrangements of bougie blockers 113, 115 and their mounting regions,according to some exemplary embodiments of the invention.

In some embodiments, a bougie 100A is configured with a two-part blocker113. Optionally, the first part 113A is the wider part. The wider part,as it is withdrawn, has the role, for example, of transitioning theinteraction of fenestrations 108A, 108B with gastric wall tissue fromexcluding-and-fixating, initially, to including-for-suturing. Thenarrower part, 113C, is optionally used to provide continued fixation ofsutured regions to the bougie during the procedure, being broken and/orwithdrawn only at the end of the procedure. In some embodiments, narrowblocker part 113C is narrow enough that it substantially allows thegastric wall tissue to pass by it, once the distal end 113B of the widerblocker part 113A is withdrawn from a fenestration pair. In someembodiments, the wall of the bougie 100A comprises a slot 111A, or pairof slots, shaped to support the blockers before removal. It is apotential advantage to leave the fenestrations fully un-joined (a bridgein the bougie wall around slot 111A), in order to provide additionalsupport for the thinner blocker.

In some embodiments, a bougie 100B comprises a single sliding blocker115 (optionally, a blocker much like blocker 102). The bougie bodyitself optionally fully separates the fenestration pairs from eachother. Optionally, an aperture slot 111B holds the sliding blocker 115in place until its removal.

Reference is now made to FIGS. 12A-12D, which schematically illustratedifferent shapes of bougie bodies 1200, 1208, 1210, 1220 according tosome exemplary embodiments of the invention.

In some embodiments of the invention, a bougie body 1210 issubstantially circular, except, for example, where interrupted byfenestration gaps 1204, and/or apertures or slots 1202 for a blocker.

In some embodiments, the walls of a bougie 1200 are thinned near thefenestration apertures 1204, for example at wall region 1206. Wallthinning near the apertures is also described in connection to wallthickening between apertures, for example, in relation to FIGS. 8A-9B,hereinabove.

In some embodiments, the overall bougie shape is non-circular. Forexample, bougie body 1208 is shown with an oval shape. A potentialadvantage of a non-circular shape is to allow a wider admission apertureat the fenestration opening, with the tradeoff of a narrower bougiedepth (which, optionally, is not required for sufficient admission oftissue).

In another embodiment type, shown in FIG. 12D, a bougie body 1220comprises a long slit 1222, sized to pass a wide blocker, and/or ablocker having a width variable over a large range. Optionally, the slit1222 is wider than the fenestration aperture 1224, allowing fullblockage of the fenestration by a sufficiently wide blocker, for exampleas described also in relation to FIGS. 7A-7F hereinabove.

Reference is now made to FIGS. 13A-13C, which show bougies 1300, 1330comprising stomach positioning/sizing extensions 1301, 1305, accordingto some exemplary embodiments of the invention.

In some embodiments of the invention, a bougie 1300, 1330 is providedwith a sizing extension 1301, 1305, which helps to position the stomachin preparation for suturing.

In some embodiments, sizing extension 1301 comprises a strip of a formedmaterial, for example, nitinol. Optionally, the extension strip ispassed into the stomach along a slot within bougie 1300, extrudes fromnear the distal end of the bougie, and wraps around to form the finalstomach-shaping brace. The stomach shaping brace comprises, for example,a narrower region at strip region 1316, where the stomach narrows beforemerging with the pylorus; a wider region 1314 at correspondingly widerregions of the stomach; a backward curve 1310 which reaches to the areaof the cardia, and/or a protective termination 1312, which can be atight curl of the strip, or simply comprise an atraumatic tip materialsuch as silicone rubber or another soft material. It is a potentialadvantage to use nitinol, which has the ability to assume a straightenedshape during passage through the bougie, while still returning fully toits natural formed shape once it is able to expand against the stomachwall. It should be understood that a sizing extension 1301 need not spanthe full extent of the stomach. In some embodiments, its role as astraightener is fulfilled by a relatively short extension outward fromthe bougie. In some embodiments, extension 1301 also serves as a wallseparator, ensuring that the left and right gastric walls mate with theappropriate fenestration regions upon application of suction.

In some embodiments of the invention, bougie 1330 comprises a sizingextension 1305 which exits the bougie body at a more proximal point1318, with a distal terminus 1320 at or near the region of the pylorus.

Reference is now made to FIGS. 13D-13E, which show bougies 1321, 1320,comprising pylorus positioning/sizing extensions 1303, 1304, accordingto some exemplary embodiments of the invention.

In some embodiments, positioning of a bougie 1321, 1320 is assisted inthe region of the pylorus by the provision of bracing fins 1303, 1304.In some embodiments, bracing fins 1303 are provided only on one side, inview of gastric asymmetry in the region of the pylorus, and allowing thebougie to be urged toward the side of the stomach from which the pylorusissues. In some embodiments, bilateral fins 1303, 1304 are provided.Optionally, fins 1304 are somewhat weaker than fins 1303, so that theydistance the bougie from the gastric wall, but still allow the bougie tobe urged to the side of the stomach from which the pylorus issues.Optionally, the finds bend out of the way to allow insertion andextraction. Optionally, inflation of balloon 106 (or provision ofpresser via another inflation fluid pathway) drives fluid such that thefins 1303, 1304 are stiffened/erected by the inflation pressure. This isa potential advantage to allow easier insertion/removal. Optionally thefins are made of nitinol which can be driven out of/withdrawn into thebougie by the advancement/retraction of a controller member fixed tothem, with the control located outside the bougie. Optionally, the finsare made of a polymer, sufficiently soft that it can collapse uponinsertion/removal through the esophagus, but expanding when there isfree room to help urge the bougie into the proper position.

Reference is now made to FIGS. 14A-14B and FIG. 15 , which show amulti-link gastric implant for forming an intra-gastric sleeve,according to some exemplary embodiments of the invention. Reference isalso made to FIG. 16 , which shows a cross-section of a multi-linkgastric implant having gastric wall tissue recruited to its hooks,according to some exemplary embodiments of the invention.

In some embodiments, gastric implant 1400 comprises a multi-link implanthaving hooks 1420. The implant 1400 is inserted to the stomach 10, forexample, through a gastroscope’s working channel, in an open loopconfiguration. Optionally, hooks 1420 are collapsed against the sides ofthe links 1410 during insertion. The implant links are initially free torotate next to one another, so that they can be positioned around thegastric wall (FIG. 14B). The free ends 1405, 1415 of the implant 1400are positioned to be near one another, and the loop is closed afterpositioning. Hooks are deployed, and the gastric walls are harvestedover the hook. To form the intra-gastric sleeve, the device issubstantially straightened. Straightening is accompanied by locking ofadjacent links to one another (FIG. 15 ). The result is a seam-likeregion. FIG. 16 shows a cross-section from this region. Links 1410 aremutually locked, with their hooks 1420 engaged with gastric tissue 1421such that it is essentially captured along two rows - one for each sideof the stomach. In some embodiments, the links occupy pouch 1426,leaving the gastric sleeve 1424 (through which food will continue topass) unobstructed.

Reference is now made to FIGS. 17A-17B, which show a self-securing clip100 for securing two gastric wall parts to one another, according tosome exemplary embodiments of the invention.

In some embodiments, self-securing clips are provided to join twostomach walls together along a line of approximation to form a gastricsleeve. FIG. 17B shows an exemplary nitinol clip (clip 1700) at its“natural” (unconstrained) shape-a body 1710 curved into a tight loop orU shape. FIG. 17A shows clip 1700 straightened, which it can beconstrained to do bending the ends apart from one another. As shown,clip 1700 has sharp tips 1722 at end of short tip shafts 1720, whichenables penetration of the ends of the clip into the gastric wall. Barbs1724, once they have penetrated, help to assure continued fixation intopenetrated tissue.

Reference is now made to FIGS. 18A-18B, which show a distal segment of adelivery system comprising a row of self-securing clips 1700 forsecuring two gastric wall parts to one another, according to someexemplary embodiments of the invention.

In some embodiments, a delivery system for clips 1700 comprises a shaft1800 and a locking strip 1810. In some embodiments, the space betweenlocking strip 1810 and shaft 1800 is restricted, such that clips 1700,contained in that space, are locked (constrained) into a straightenedposition in between them (FIG. 18A).

FIG. 18B shows the same shaft 1800 and locking strip 1810 during aprocess of releasing clips 1700. As strip 1810 is pulled proximally,clips 1700 are sequentially released from their constraints. This freesthem to self-shape to their natural curved configuration. Shown is astage in which seven distal clips 1700 are released, while the restremain locked.

In some embodiments, shaft 1800 includes vacuum ports 1820 in betweenthe clips. Optionally, vacuum applied to the shaft helps to pull tissueinto apposition, impaling it to the sharp ends 1722 of the clips 1700,resulting in clip fixation.

Reference is now made to FIGS. 19A-19F, which show details of theconstruction of a shaft 1800 of a delivery system for self-securingclips 1700, according to some exemplary embodiments of the invention.

FIGS. 19A-19B illustrate shaft 1800 from a perspective side view:overall (FIG. 19A), and in detail (FIG. 19B) for region 1800B. Thepositions of vacuum ports 1820 are indicated.

FIGS. 19C-19D illustrate median vertical cross-sections of shaft 1800,and, in particular, detail of region 1800D. Shaft 1800 includeslongitudinal slit/hole 1830, through which strip 1810 slides. Grooves1840 located along slit 1830 are sized to contain and geometrically lockclips 1700.

FIGS. 19E-19F show (in horizontal cross-section) vacuum canals 1825,which connect to vacuum ports 1820 along the sides, and, in particular,detail of region 1800F. In some embodiments, there are two vacuum canals1825 which are independently operable. Potentially, this allows grabbinggastric wall tissue in sequence-first by applying vacuum to one side andimpaling a first wall region, then by applying vacuum to the other side,and impaling a second wall region.

Reference is now made to FIGS. 20A-20C, which demonstrate a sequence ofapproximating a segment of the stomach’s walls, according to someexemplary embodiments of the invention.

In FIG. 20A, device 1800 is shown fixated to a first wall 2000A.Fixation occurs, for example, upon applying a vacuum in the adjacentvacuum canal to impale nearby tissue upon clips 1700. In FIG. 20B,device 1800 is shown additionally fixated to the second wall 2000B,after approximation to the wall, and application of vacuum in the secondcanal. In FIG. 20C, strip 1810 has been pulled, allowing clips 1700 tobend and self-secure, and the delivery system removed. The walls 2000A,2000B are left clipped (FIG. 20C).

For simplicity, the drawings show a straight shaft segment. It is to beunderstood, however, that the delivery system, in some embodiments,comprises a curved shaft. For example, the shaft is curved to morenaturally follow the curvature of the gastric anatomy.

Reference is now made to FIGS. 21A-21C, which demonstrate a clippingdevice integrated with conventional gastrointestinal means such asbougie and endoscope/gastroscope, according to some exemplaryembodiments of the invention.

In some embodiments (FIG. 21A), shaft 1800 is connected to bougie 2100along one side of the bougie 2100. Optionally, removable covers 1860 areprovided to cover the clips. This potentially enables transoralinsertion into the stomach without scratching/injury of thegastrointestinal tract by the clips 1700. Optionally, bougie 2100 ismade of a transparent material (for instance, polyethylene, cyclicolefin copolymer, polycarbonate, polyolefin, polyurethane, fluorinatedethylene propylene, polyethylene terephthalate, or another polymer)which assists operator visualization during operation of a gastroscope2150 placed inside its lumen.

In some embodiments, bougie 2100 is perforated by holes 2110, whichenable applied vacuum suction to pull and place the gastric wall aroundthe circumference of bougie 2100. The vacuum inside holes 2110 istransmitted, for example, by suction applied to an aperture of bougielumen 2110, by applying suction through a working channel of gastroscope2150, and/or by canals (not shown) embedded along a wall of bougie 2100.

After the clipping device is inserted into the stomach (FIG. 21B), thephysician optionally switches vacuum on and off (while maintainingcovers 1860) repeatedly, together with movements of the device, untilthe device is well positioned.

Afterwards (FIG. 21C) the physician removes covers 1860, accessing them,for example, from a distal aperture of bougie 2100, and/or releasing acatch accessible from within the bougie 2100. Cover release exposesclips 1700 which penetrate (optionally assisted by a vacuum force whichpulls the tissue) into the gastric walls 2000. In FIG. 21C, aspreviously described, strip 1810 has been pulled, clips 1700 arereleased, and an intra-gastric sleeve created. In some embodiments, asingle long clipping device is used to clip the entire gastric sleeve atonce. In some embodiments, clipping devices are separately applied insegments along the gastric sleeve.

Reference is now made to FIGS. 22A-22B, which illustrate asemi-automatic suturing device 2200 for driving a needle along apartially open spiral path, and repeatedly through tissue fixed to thedevice, according to some exemplary embodiments of the invention. FIG.22B shows additional detail of region 2250 of FIG. 22A.

In some embodiments, the suturing device 2200 comprises casing tube 2210and driving tube 2220. It should be noted that in the drawing, a portion2221 of casing tube 2210 is shown in cutaway to allow visualization ofthe driving tube 2220 underneath. Optionally, one or both of tubes 2210,2220 are polymer made, and substantially transparent. Potentially, thisallows endoscopic visualization from within their lumen. In someembodiments, casing tube 2210 comprises an outer jacket 2211 whichpartially wraps the circumference of casing tube 2210 (for example,between 230°-300° of the circumference; as shown, about 270° of thecircumference).

In some embodiments, the jacket 2211 comprises a plurality oflongitudinal slits 2212, to which the gastric wall is drawn to begrasped (for example, by applying of vacuum). In some embodiments,jacket 2211 comprises a helical slot 2215, which is optionally partiallyor fully interrupted around the circumference of the casing tube 2210 atthe boundaries of jacket 2211. In some embodiments, helical slot 2215and longitudinal slits 2212 occupy common lumens. In some embodiments,they comprise separate channels.

In some embodiments, a needle 2300 is provided, sized for travellingaround helical slot 2215. The needle 2300 is connected with a suturethread. Where needle 2300 exits the jacket 2211, it potentiallyencounters tissue, such as gastric wall tissue suctioned to the device.A potential advantage of combining the lumens of slot 2215 and slits2212 is to enhance fixation at the direct point of penetration by needle2300.

Optionally, the device comprises a proximal balloon 2230 and/or distalballoon 2240, for sealing (against vacuum) and/or fixation.

Reference is now made to FIGS. 23A-23D, which demonstrate the drivingmechanism of a needle 2300, according to some exemplary embodiments ofthe invention. FIG. 23A repeats the structure of device 2200 shown inFIG. 22A, for ease of reference. FIGS. 23B-23C comprise illustrations ofcomponents of device 2200. FIG. 23D schematically illustrates a cutawayview of device 2200, looking longitudinally along the axis of drivingtube 2220 at a level which the needle 2300 occupies.

In some embodiments, needle 2300 is connected to thread 2350, which isstored, for example, underneath balloon 2240. In some embodiments,needle 2300 comprises a plurality of flexible latches 2310. Uponrotation of driving tube 2220, longitudinal protrusions 2222 of thedriving tube 2220 push on flexible latches 2310, driving needle 2300along helical groove 2215 and through the tissue being held alonglongitudinal slits 2212.

Operation begins with the system placed inside the gastric cavity, forexample, under visualization. Visualization is performed by, forexample, under fluoroscopy or by using an endoscope (optionally avideoscope-type endoscope) inside the system, and/or another imagingmethod. In some embodiments, the operator then deploys the proximal(2230) and distal (2240) balloons to seal the gastric inlet and outlet.Potentially, this enhances stability when applying vacuum through thedevice lumen and its grooves. Upon application of vacuum, the stomachshrinks against the suturing device 2200, for example, substantially asshown in FIG. 21B: gastric wall tissue surrounds the device, with excesstissue collapsed.

As the gastric walls collapse around casing tube 2210 and jacket 2211,the gap in the jacket 2211 is also filled in, and tissue brought to theexit apertures of longitudinal slits 2215. Upon rotation of driving tube2220, needle 2300 is forced into the gastric wall tissue. The needle islong enough that the tip passes back into the jacket before the otherend exits, assuring continuous containment of the needle. The drivinglatches 2310 are spaced along the needle 2300 such that while one isoutside the suture device (in the tissue, for example), at least oneother latch is within the device and usable for driving the needle 2300.The depth of the jacket and/or the position of the exiting needle 2300from slits 2215 determines the depth at which the suture needle willpass through the tissue.

The needle is driven continuously around the device, until a sufficientlength of the gastric sleeve is sutured. If performed undervisualization, the operator can make the decision based on directvisualization. Alternatively, a predetermined number of rotations aremade. The pitch of slits 2215 is, for example, between 0.8 cm and 2 cm,or another greater, larger, or intermediate pitch, according to thedistance at which sutures are to be made.

After suturing, the operator removes the suturing device. In someembodiments, the suturing device 2200 is removable in pieces, to preventsuturing-in of the device during operation. For example, driving tube2220 and/or casing tube are removable separately from jacket 2211. Insome embodiments, the floor (in the jacket 2211) of slits 2215 are open,allowing it to separate from the suture thread upon removal.

Freed from the device, suturing thread 2350 is tightened, approximatingand/or ensuring continued approximation of the gastric walls to eachother. Optionally, a locking element is passed over the thread andsecured to maintain a tight suture. In some embodiments, a barbed sutureis used to maintain fixation. The result is an intralumenally-createdgastric sleeve, created without a requirement for making a surgicalopening.

As used herein, the term “about” refers to within ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean: “including but not limited to”.

The term “consisting of” means: “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The words “example” and “exemplary” are used herein to mean “serving asan example, instance or illustration”. Any embodiment described as an“example” or “exemplary” is not necessarily to be construed as preferredor advantageous over other embodiments and/or to exclude theincorporation of features from other embodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment of the invention may include a plurality of “optional”features except insofar as such features conflict.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

It is the intent of the applicant(s) that all publications, patents andpatent applications referred to in this specification are to beincorporated in their entirety by reference into the specification, asif each individual publication, patent or patent application wasspecifically and individually noted when referenced that it is to beincorporated herein by reference. In addition, citation oridentification of any reference in this application shall not beconstrued as an admission that such reference is available as prior artto the present invention. To the extent that section headings are used,they should not be construed as necessarily limiting. In addition, anypriority document(s) of this application is/are hereby incorporatedherein by reference in its/their entirety.

What is claimed is:
 1. A system for gastric reshaping including: abougie for shaping a portion of a stomach to receive sutures, saidbougie comprising: a flexible wall sized and shaped to define a gastricpassageway for food; a plurality of spaced wall fenestrationslongitudinally distributed along the flexible wall, wherein saidplurality of fenestrations are configured such that vacuum applied tosaid fenestrations cause collapse of the stomach portion onto saidbougie; at least one sensor configured to sense a leak in the stomach;and circuitry configured to receive a signal from said sensor andconfigured to generate an alert when a leak in the stomach is indicatedby said sensor.
 2. The system of claim 1, wherein said at least onesensor is configured to detect leakage within a range of about ±0.001bar.
 3. The system of claim 1, wherein said at least one sensor isconfigured to detect leakage within a range of about ±0.005 bar.
 4. Thesystem of claim 1, wherein said sensor is configured to detect a changein one or more properties of the vacuum.
 5. The system of claim 1,wherein the change in one or more properties of the vacuum indicates apenetration through a wall of the stomach.
 6. The system of claim 1,wherein said sensor is configured to detect a change in vacuum pressurein said bougie.
 7. The system of claim 6, wherein said change in vacuumpressure indicates a potential leak in said bougie.
 8. The system ofclaim 1, wherein said bougie is provided with a pyloric region seal andan esophageal/cardia region seal configured to stabilize a vacuumpressure within said bougie.
 9. The system of claim 1, wherein at leastone of a leak, a sudden change in pressure, and a sudden change in flowis detectable by said at least one sensor.
 10. The system of claim 9,wherein said sensor is coupled to at least one of a vacuum source and toa line to said bougie.
 11. The system of claim 1, wherein said system isconfigured to monitor vacuum pressure within said bougie and to send analert indicating a change in pressure.
 12. The system of claim 1,wherein pressure in said bougie is maintainable by feedback, wherein achange in pressure and/or flow in said bougie is detectable and whereinsaid feedback includes transmission of an alert.
 13. The system of claim1 including a leak indicator.
 14. A method for gastric reshaping, saidmethod including: inserting a bougie into a stomach; applying vacuumthrough the bougie to collapse a portion of a stomach wall onto thebougie; one of detecting a leak in the stomach and detecting apenetration through the stomach wall; transmitting a signal from thesensor to indicate at least one of a leak in the stomach, a penetrationthrough the stomach wall, and a change in the vacuum; receiving thesignal by circuitry and generating an alert if at least one of a leak inthe stomach, a penetration through the stomach wall, and a change in thevacuum is indicated by the signal.
 15. The method according to claim 14,wherein said applying vacuum includes applying vacuum through aplurality of fenestrations in a wall of the bougie and receiving tissueof the stomach wall in the plurality of fenestrations.
 16. The methodaccording to claim 15, wherein said receiving tissue includes drawingtissue from opposing sides of the stomach to the bougie wall such thatthe tissue wraps around the bougie and partially intrudes into thefenestrations.
 17. The method according to claim 16, including suturingthe drawn tissue from the opposing sides to each other.
 18. The methodaccording to claim 17, wherein said suturing includes piercing the drawntissue in a non-penetrating manner which does not exit the stomach. 19.The method according to claim 17, including viewing the tissue fromwithin the bougie prior to said suturing.